EPI-DERM SILICONE GEL SHEETING
Device Facts
| Record ID | K003948 |
|---|---|
| Device Name | EPI-DERM SILICONE GEL SHEETING |
| Applicant | Biodermis Corp. |
| Product Code | MDA · General, Plastic Surgery |
| Decision Date | Jan 29, 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.
