ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057

K020296 · Apothecary Products, Inc. · EWD · Jun 25, 2002 · EN

Device Facts

• Record ID: K020296
• Device Name: ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
• Applicant: Apothecary Products, Inc.
• Product Code: EWD · EN
• Decision Date: Jun 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

Adult Silicone Ear Plugs are used for protection from noise. This device is for adult use only.

Device Story

Adult Silicone Ear Plugs are personal protective devices designed to reduce noise exposure. The device consists of silicone material molded by the user to fit the external ear canal. It functions as a physical barrier to sound waves. Used by adults in environments where noise reduction is desired. The device is non-electronic and requires no clinical operation or interpretation of output.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone material; physical noise barrier; manual form factor; non-electronic; no software.

Indications for Use

Indicated for noise protection in adults. Contraindications not specified.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Apothecary Products, Inc. c/o Greg Larson 11750 12th Ave. S. Burnsville, MN 55337

Re: 510(K) Number: K020296 Device Name: Adult Silicone Ear Plugs Regulatory Class: Unclassified Product Code: EWD Dated: January 23, 2002 Received: January 28, 2002

Dear Mr. Larson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

JUN 2 5 2002

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

## Page 2 - Greg Larson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

Ver/ 3 - 4/24/96

| Applicant: | Apothecary Products, Inc. |
|---------------------------|---------------------------|
| 510(k) Number (if known): | NA |
| Device Name: | Adult Silicone Ear Plug |
| Indications For Use: | |

Adult Silicone Ear Plugs are used for protection from noise. This device is for adult use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109) (Optional Format 1-2-96)

Kira Bohn

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K020896