ENSIL FABRIC
Device Facts
| Record ID | K010675 |
|---|---|
| Device Name | ENSIL FABRIC |
| Applicant | Gottfried Medical, Inc. |
| Product Code | MDA · General, Plastic Surgery |
| Decision Date | May 30, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4025 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
