NASAL DORSAL SERIES

K983755 · Surgical Technology Laboratories, Inc. · FZE · Nov 20, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K983755
• Device Name: NASAL DORSAL SERIES
• Applicant: Surgical Technology Laboratories, Inc.
• Product Code: FZE · General, Plastic Surgery
• Decision Date: Nov 20, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Surgical Technology Laboratories, Inc. Nasal Dorsal Series implants are intended to be used to augment or reconstruct the nose in rhinoplasty.

Device Story

Nasal Dorsal Series implants are surgical devices used for nasal augmentation or reconstruction during rhinoplasty procedures. The device is intended for use by surgeons in a clinical or hospital setting. It serves as a structural implant to reshape or augment the nasal dorsum. The healthcare provider selects and implants the device to achieve desired aesthetic or functional nasal outcomes, potentially benefiting the patient by correcting nasal deformities or enhancing nasal profile.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nasal implant for rhinoplasty. Specific materials and technical specifications not detailed in the provided documentation.

Indications for Use

Indicated for patients undergoing rhinoplasty requiring nasal augmentation or reconstruction.

Regulatory Classification

Identification

A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1998

Mr. Richard T. Nock Vice President Surgical Technology Laboratories, Inc. 1588 East 40th St. Cleveland, Ohio 44103

Re: K983755 Trade Name: Nasal Dorsal Series Regulatory Class: II Product Code: FZE Dated: October 16, 1998 Received: October 22, 1998

Dear Mr. Nock:

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.

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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.

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## Page 2 - Mr. Richard T. Knock

This letter will allow you to begin marketing your device as described in your 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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Jocelyn

- Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Surgical Technology Laboratories, Inc. The logo is in bold, black font. The address of the company is listed as 1588 East 40th St. Cleveland, Ohio 44103. The date '98-11-19 11:35 SURGIFORM is printed at the top of the image.

Image /page/2/Picture/1 description: The image shows a series of bold, black handwritten characters against a white background. The characters appear to be 'KA69755', with some additional markings above the last two digits. The style of writing is thick and somewhat stylized, giving the impression of a quickly written or stylized font.

[phone]

510(k) Number (if known): K_983755

Device Name: Nasal Dorsal Series

Indications for Use:

Surgical Technology Laboratories, Inc. Nasal Dorsal Series implants are intended to be used to augment or reconstruct the nose in rhinoplasty.

**Prescription Use**
**(Per 21 CFR 801.109)**

Oceano

of General Restorative Devices 4837