NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')

K093109 · Novo Nordisk, Inc. · FMI · Jun 18, 2010 · General Hospital

Device Facts

• Record ID: K093109
• Device Name: NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
• Applicant: Novo Nordisk, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Jun 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NovoTwist needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide and somatropin.

Device Story

NovoTwist needle is a sterile, single-use disposable hypodermic needle designed for subcutaneous drug delivery. It attaches to pen injector devices via a bayonet coupling mechanism; user presses and twists a quarter-turn until a confirmatory click is heard. This mechanism replaces traditional multi-turn threading to reduce attachment time and ensure correct seating. Device is used by patients or healthcare professionals in home or clinical settings. Input is the physical attachment to a pen injector; output is the delivery of medication (insulin, liraglutide, somatropin) into subcutaneous tissue. The device features a protective tab and caps for safety. Benefits include improved ease of use and audible confirmation of secure attachment, reducing potential for user error during needle mounting.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including 34 mechanical and visual design verification tests (e.g., bubble leak, needle point defects, bond strength) per ISO 11608-2, ISO 11607-1, and ISO 7864. Biocompatibility is established by referencing identical materials to predicate devices (ISO 10993-1).

Technological Characteristics

Single lumen hypodermic needle. Materials: Polypropylene hub/outer cap, Polyethylene inner cap, Stainless steel (AISI 304) cannula, epoxy adhesive, silicone oil lubricant. Bayonet coupling attachment. Sterilized via steam. Complies with ISO 11608-2, ISO 11607-1, ISO 7864, and ISO 13485.

Indications for Use

Indicated for patients requiring subcutaneous injection of insulin, liraglutide, or somatropin using compatible pen injector devices.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• NovoFine 32G Tip (K062500, K090111)
• NovoFine Autocover 30G (K050106)
• BD Pen needle (K051899)

Submission Summary (Full Text)

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Koa 3109

NovoTwist needle Disposable Needle Novo Nordisk Inc.

CONFIDENTIAL

Date: Version Status: Page:

June 2010 Novo Nordisk 1

Final Page 2 of 8

# JUN 1 8 2010

807.87(h) 510(k) Summary

As required by Section 807.92 (a)

#### (1) DATE OF PREPARATION: 2010-6-9

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. NovoTwist® needle meets all applicable product and quality standards for hypodermic single lumen needle products.

#### SUBMITTER'S NAME AND ADDRESS:

Novo Nordisk Inc. Contact Person: 100 College Road West Cindy Cao, Ph. D. Princeton, New Jersey 08540 Tel: [phone] Fax: [phone]

### (2) NAME OF DEVICE:

| Proprietary Name: | NovoTwist® needle |
|-----------------------|--------------------------------------------------|
| | 30G x 8 mm |
| | 32G Tip x 5mm |
| Common or usual name: | Sterile disposable hypodermic needle |
| Classification: | Hypodermic single lumen needle (21 CFR 880.5570) |
| Class: | Class II |

### (3) SUBSTANTIAL EQUIVALENCE:

Novo Twist® 30G and 32G Tip needles are disposable needles which are substantially equivalent to the Novo Nordisk's NovoFine® 32G Tip (0.23/ 0.25 mm) x 6 mm disposable needle, cleared under 510(k) K062500 and K090111, to the NovoFine® Autocover® 30G x 8 mm disposable needle, cleared under 510(k) K050106, and to the BD Pen needle, cleared under 510(k) K051899.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and supplied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statement related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US patent laws or their applications by the court.

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NovoTwist needle Disposable Needle Novo Nordisk Inc.

CONFIDENTIAL

Date: Version: Status: Page:

June 2010 Novo Nordisk 1 Final Page 3 of 8

### 807.87(h) 510(k) Summary (continued)

#### (4) DEVICE DESCRIPTION:

NovoTwist® needle is designed for single use in conjunction with Novo Nordisk injection delivery devices built with bayonet coupling. Prior to giving an injection, the protective tab is removed from the outer needle cap of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then pressed onto the injection delivery device with a bayonet coupling and twisted a quarter of a revolution until tightness and a confirmatory click is heard. Then the outer and inner caps of the needle are removed. Injection is performed by following the procedure described in the User Manual provided with the pen injection device and instructions from your health care professional.

After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, another disposable needle must be used. Function checks for the delivery device can be performed with the NovoTwist® needles by using the needle cap.

The NovoTwist® needle is used in exactly the same manner as the NovoFine® and the BD Pen needle except it is built with an improved attachment mechanism. NovoTwist® needle is attached to the delivery device via a bayonet thread. This allows the user to press down and twist the needle a quarter of a revolution instead of tightening through several revolutions as with the NovoFine® needle, BD pen needle, and many other commercially marketed hypodermic needles that operate on the same principles. This improved mechanism is intended to reduce the attachment time. In addition, users can hear a confirmatory click when the NovoTwist® needle is attached correctly to the device. This user friendly feature is designed to ensure the needle is attached to the device correctly before beginning the injection.

### (5) INTENDED USE:

Novo Twist needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide and somatropin.

#### (6) TECHNOLOGICAL CHARACTERISTICS:

The NovoTwist® needle is considered substantially equivalent to the NovoFine® 32G Tip needles, the NovoFine Autocover 30G needles, and the BD pen needles in intended use, technology, principle of operation, materials and performance. For a detailed side by side comparison to

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| NovoTwist needle<br>Disposable Needle<br>Novo Nordisk Inc. | CONFIDENTIAL | | Date:<br>Version:<br>Status:<br>Page: | June 2010<br>1<br>Final<br>Page 4 of 8 | Novo Nordisk |
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### 807.87(h) 510(k) Summary (continued)

Novo Nordisk's NovoFine needles and the BD needles cleared by the Agency, please see Table 1: Comparison to a legally marketed device. N/A is used where the documentation is considered to be proprietary information of BD.

Materials in NovoTwist® 30G are identical to those in the NovoTwist® 32G Tip needles. NovoTwist® needles consist of almost the same components and materials as NovoFine® Autocover® 30G and NovoFine® 32G Tip needles. A detailed side by side comparison of the materials in NovoTwist® 30G and 32G Tip needles with those in the NovoFine® needles is presented in Table 2: Material description of NovoTwist®.

In conclusion, the difference between the NovoTwist® and the NovoFine® and BD Pen needles is the attachment mechanism, and it does not raise any significant issues of safety and effectiveness.

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NovoTwist® needle
Disposable Needle
Novo Nordisk Inc.

Novo Nordisk

| Parameters | Marketing Status | Intended use | Product type<br>Materials<br>Durability | Biocompatibility | Reuse<br>Labeling | Specifications | NovoTwist® 32G Tip | NovoTwist® 30G | NovoFine® 32G Tip<br>K062500, K090111 | NovoFine® Autocover® 30G<br>K050106 | BD Pen Needle 29G, 30G, 31G<br>K051899 |
|-------------------------------------|------------------|---------------------------------------------------------------------|-----------------------------------------|------------------------------|--------------------------------------|-----------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------|------------------------------------------------------------------------|
| | | | | | | | TBD | TBD | | | |
| | | Subcutaneous injection of<br>insulin, liraglutide and<br>somatropin | Hypodermic pen needle<br>See Table 2 | 2 years from production date | DS/EN ISO 10993-1, see<br>Appendix E | N/A - single use<br>See Section 5 | Subcutaneous injection of<br>insulin, liraglutide and<br>somatropin | Subcutaneous injection of<br>insulin, liraglutide and<br>somatropin | Subcutaneous injection of<br>insulin, liraglutide and<br>somatropin | Subcutaneous injection of<br>insulin | Subcutaneous injection of<br>drugs, including insulin<br>and exenatide |
| | | | | | | | Hypodermic pen needle<br>See Table 2 | Hypodermic pen needle<br>See Table 2 | Hypodermic pen needle<br>See Table 2 | -Hypodermic pen needle<br>See Table 2 | Hypodermic pen needle |
| | | | | | | | 2 years from production date | 2 years from production date | 5 years from production<br>date | 3 years from production<br>date | N/A |
| | | | | | | | DS/EN ISO 10993-1, see<br>Appendix E | DS/EN ISO 10993-1, see<br>Appendix E | DS/EN ISO 10993-1, see<br>Appendix E | DS/EN ISO 10993-1,<br>Appendix E | N/A |
| | | | | | | | N/A - single use<br>See Section 5 | N/A-single use<br>See Section 5 | N/A - single use<br>See Section 5 | N/A - single use<br>See Section 5 | N/A - single use |
| Outer Diameter,<br>Tip | | | | | | | 0.22-0.25 mm | 0.30-0.32 mm | 0.22-0.25 mm | 0.30-0.32 mm | N/A |
| Outer Diameter,<br>cylindrical part | | | | | | | 0.25-0.27 mm | 0.165-0.185 mm | 0.25-0.27 mm | 0.165-0.185mm | 5, 8, 12.7 mm<br>31, 30, 29 |
| Inner Diameter | | | | | | | 0.145-0.16 mm<br>0.03-0.053 mm | N/A | 0.145-0.16 mm<br>0.03-0.053 mm | N/A | N/A |
| Wall Thickness,<br>Tip | | | | | | | 0.045-0.063 mm | 0.058-0.078 mm | 0.045-0.063 mm | 0.058-0.078 mm | N/A |
| Wall Thickness,<br>Cylindrical part | | | | | | | 14.82-15.88 mm | 17.85-18.85 mm | 15.82-16.88 mm | 33.87-34.93 mm | N/A |
| Total Length | | | | | | | 5 mm | 8 mm | 6 mm | 8 mm | N/A |
| Length from Hub | | | | | | | | 30 | | 30 | N/A |
| Gauge | | | | | | | 31/32 Tip | | 31/32 Tip | | N/A |
| Tip Configuration | | | | | | | 1.st and 2.nd grinding and<br>glass blasting | 1.st and 2.nd grinding and glass<br>blasting | 1.st and 2.nd grinding and<br>glass blasting | 1.st and 2.nd grinding and<br>glass blasting | N/A |
| Cover Color | | | | | | | Light Blue (RAL 5012) | Yellow (RAL 1021) | Light Blue (RAL 5012) | Yellow (Pantone 116U) | N/A |
| Cover Strength | | | | | | | Pmin = 56mBar<br>Fmin = 22 N | Pmin = 56mBar<br>Fmin = 22 N | Pmin = 70mBar<br>Fmin = 22 N | Pmin = 70mBar<br>Fmin = 22 N | N/A |
| Hub/Sneedlezbond strength | | | | | | | N/A | N/A | N/A | N/A | N/A |
| Needle Stick Prevention<br>Features | | | | | | | N/A | N/A | N/A | Passive/Automatic | N/A |
| Activation Process | | | | | | | N/A | N/A | N/A | Visual | N/A |
| Safety Indicator | | | | | | | N/A | N/A | N/A | No | N/A |
| Safety Override | | | | | | | N/A | N/A | N/A | N/A | N/A |

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| NovoTwist needle | | Date: | June 2010 | Novo Nordisk |
|-------------------|--------------|----------|-------------|--------------|
| Disposable Needle | CONFIDENTIAL | Version: | 1 | |
| Novo Nordisk Inc. | | Status: | Final | |
| | | Page: | Page 6 of 8 | |

#### Material description of NovoTwist® needles: Table 2

| Component | NovoTwist® 30G and 32G Tip1<br>Manufacturing site NMS | NovoFine® Autocover® 30G2<br>Manufacturing site NMS | NovoFine® 32G Tip<br>Manufacturing site Nipro, Japan |
|-------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| 1. The hub | Polypropylene (PP)<br>Color: White | Polypropylene (PP)<br>Color: Moplen HP548R<br>Or Moplen HP548R White<br>Or RF365MO Neutral | Polypropylene (PP) |
| 2. Glue | Eccobond, 927-10-EF<br>One component epoxy adhesive<br>Color: Light yellow | Eccobond, 927-10-EF<br>One component epoxy adhesive<br>Color: Light yellow | Eccobond 927-10-E<br>One component epoxy adhesive<br>Color: Light yellow |
| 3. The inner cap | Polyethylene (PE)<br>Color: Transparent | N/A | Polyethylene (PE) |
| 4. The outer cap | Polypropylene (PP)<br>Color: Transparent Blue | Polypropylene (PP)<br>Color: Moplen HP548R<br>Or Moplen HP548R White<br>Or RF365MO Neutral | Polypropylene (PP) |
| 5. The cannula | Stainless steel<br>AISI 304/JISG 4305<br>DIN-kurzname: X 5 CrNi 18 9 | Stainless steel<br>AISI 304/JISG 4305<br>DIN-kurzname: X5 CrNi 18 9 | Stainless steel<br>AISI 304/JISG 4305<br>DIN-kurzname: X 5 CrNi 18 9 |
| Ad 5. Lubricating oil<br>for the patient needle | MDX4-4159<br>Medical Grade Dispersion<br>(partly hardened silicone) | MDX4-4159<br>Medical Grade Dispersion<br>(partly hardened silicone) | MDX4-4159<br>Medical Grade Dispersion<br>(partly hardened silicone) |
| Ad 5. Lubricating oil<br>for the back needle | Medical Fluid Silicone Oil<br>12500 cSt | Medical Fluid Silicone Oil<br>12500 cSt | Medical Fluid Silicone Oil<br>12500 cSt |
| 6. The sealing paper/<br>protective tab | Gas permeable sealing paper<br>60 g/m² for steam sterilization | Gas permeable sealing paper<br>60 g/m² for steam sterilisation | Bactite 60K 43 g/m² coated with<br>PS-118 lacquer 6 g/m² for<br>ethylene oxide sterilization |

Note 1: See Figure 3 regarding the drawing of individual components.

Note 2: Some of the specific components and materials used for NovoFine® Autocover® 30G is not shown in the table as they are related to the unique shield mechanism of prevention of needle stick injuries.

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Novo Twist needle Disposable Needle Novo Nordisk Inc.

CONFIDENTIAL

Date: Version: Status: Page:

June 2010 1 Final

Novo Nordisk

Page 7 of 8

**Final**
of 8

### 807.87(h) 510(k) Summary (continued)

As required by Section 807.92(b) .

(1) NON-CLINICAL TESTS:

Novo Twist® 30G and 32G Tip needles have been subjected to many non-clinical tests throughout the development by Novo Nordisk R&D, and these tests comply with ISO 11608-2:2000 Peniniectors for medical use - Part 2: Needles - Requirements and test methods.

First, several prototype tests with NovoTwist® needles were conducted to evaluate the performance and functionality of the needles.

Second, NovoTwist® needles are subjected to a final design verification test. The needle samples tested are manufactured, sterilized, packaged and labelled on validated equipment and QA-released in accordance with cGMP for Medical Devices (ISO 13485:2003 Medical devices - Quality management systems Requirements for regulatory purposes). The final design verification test consists of 34 mechanical and visual tests (Appendix D of original 510(k) submission). Some of the key design verification tests performed include the bubble leak test to ensure sterility in accordance with ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems; Freedom from defects in accordance with ISO 7864:1993 Sterile hypodermic needles for single use, i. e. defect needle point, patient needle point, silicone on patient-end needle, bond between hub and needle tube and visual control of quality of sealing. In summary, the final design verification test supports that Novo Twist needles meet the specified requirements and that the needles can be safely used in various real-life situations of handling and use according to Instructions for Use.

Third, shelf life test has been performed on final released NovoTwist® 30G and 32G Tip needles in accordance with ISO 11607-1:2006 (see Appendix 3 in the submission of June 10, 2010).

Fourth, the cannula and silicone oil are the only components of the needle in contact with human tissue, and the composition of the cannula and silicone oil of NovoTwist® needles are identical to that of NovoFine® needles, the substantially equivalent device (see Table 2). Therefore we reference the biocompatibility tests to those previously conducted for the NovoFine needles in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system, which have been cleared by the Agency (see Appendix E in the original 510(k) submission).

Finally, handling test and usability test are performed (see Appendix G in the original submission).

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| NovoTwist® needle<br>Disposable Needle<br>Novo Nordisk Inc. | CONFIDENTIAL | Date:<br>Version:<br>Status:<br>Page: | June 2010<br>1<br>Final<br>Page 8 of 8 | Novo Nordi |
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The NovoTwist needles are manufactured in accordance with current Good Manufacturing Practices for Medical Devices.

#### (2) CLINICAL TESTS:

No clinical tests are required.

### (3) CONCLUSIONS DRAWN FROM THE NON-CLINICAL AND CLINICAL TESTS:

Based on the design equivalency and the finctional testing, Novo Nordisk had determined that the Block on the using equivalent of the Novolines " 30 of Tip acede (K062500,
NovoTwist" needle is substantially equivalent to the Novolline" 32G States of Story of which are currently marketed in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness.

Date

Mary Ann McElligott, Ph.D. Associate Vice President, Regulatory Affairs Novo Nordisk Inc.

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Image /page/7/Picture/1 description: The image is a circular seal with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with three thick, curved lines forming its wings and body, giving it a modern and abstract appearance.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

## JUN 1 8 2010

Cindy Cao, Ph.D. Senior Manager, Regulatory Affairs Novo Nordisk Incorporated 100 College Road West Princeton, New Jersey 08540-7810

Re: K093109

Trade/Device Name: NovoTwist® Needle, Models 30G x 8mm (1/3") & 32G Tip x 5mm (1/5") Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: June 10, 2010 Received: June 11, 2010

Dear Dr. Cao:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Dr. Cao

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Quiroz

Anthony D. watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NovoTwist® needle 510(k) - K093109 Novo Nordisk Inc.

CONFIDENTIAL

Date: Version: Status: Page:

l Final

Page 12 of 16

### Indications for Use Statement

K093109 510(k) Number (if known)

Device Name:

NovoTwist® needle

32G Tip x 5mm Disposable Needle

30G x 8mm Disposable Needle

Indications For Use:

NovoTwist® needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide and somatropin .

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

N

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(Division Director)

510(k) Number: K093109

⁽Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices