SURGICAL APPAREL
Device Facts
| Record ID | K935199 |
|---|---|
| Device Name | SURGICAL APPAREL |
| Applicant | Associated Hospital Services, Inc. |
| Product Code | KKY · General, Plastic Surgery |
| Decision Date | Sep 30, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3500 |
| Device Class | Class 2 |
Regulatory Classification
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.
