SILIMED NASAL L SHAPED IMPLANT

K981833 · Silimed, LLC · FZE · Jun 26, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981833
• Device Name: SILIMED NASAL L SHAPED IMPLANT
• Applicant: Silimed, LLC
• Product Code: FZE · General, Plastic Surgery
• Decision Date: Jun 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Silimed Nasal Implant is designed to be used for augmentation and reconstruction of the nasal contour. It is radiopaque and may be trimmed. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Device Story

Silimed Nasal 'L' Shaped Implant is a solid, radiopaque silicone device used for nasal augmentation and reconstruction. Designed for surgical implantation by a physician to restore or enhance nasal contour. The device is trimmable to fit individual patient anatomy. It functions as a structural implant to provide support and shape to the nasal structure.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review.

Technological Characteristics

Solid silicone nasal implant; radiopaque; trimmable; Class II device; Product Code FZE.

Indications for Use

Indicated for augmentation and reconstruction of the nasal contour in patients requiring nasal surgery.

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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JUN 26 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SILIMED, LLC ·E.J. Smith c/o Smith Associates P.O. Box 4341 Crofton, Maryland 21114

Re: K981833 Trade Name: Nasal "L" Shaped Implant Regulatory Class: II Product Code: FZE Dated: May 26, 1998 Received: May 26, 1998

Dear E.J. Smith:

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 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 requirement, 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.

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Page 2 - E.J. Smith

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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## K981833 510(k) Number (if known):

Device Name: Silimed Nasal "L" Shaped Implant

Classification Panel: ESS

## Indications for Use:

The Silimed Nasal Implant is designed to be used for augmentation and reconstruction of the nasal contour. It is radiopaque and may be trimmed.

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
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| Prescription Use<br>✓ | or | Over-the-Counter Use |


| (Division Sign-Off) | |
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| Division of General Restor devices | |
| 510(k) Number | K981833 |