← Product Code [KKY](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY) · K935199

# SURGICAL APPAREL (K935199)

_Associated Hospital Services, Inc. · KKY · Sep 30, 1994 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-d%E2%80%94prosthetic-devices/KKY/K935199

## Device Facts

- **Applicant:** Associated Hospital Services, Inc.
- **Product Code:** [KKY](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY.md)
- **Decision Date:** Sep 30, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3500
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-d%E2%80%94prosthetic-devices/KKY/K935199](https://fda.innolitics.com/submissions/HO/subpart-d%E2%80%94prosthetic-devices/KKY/K935199)

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