IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
Device Facts
| Record ID | K964846 |
|---|---|
| Device Name | IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING |
| Applicant | Implantech Associates, Inc. |
| Product Code | MDA · General, Plastic Surgery |
| Decision Date | Feb 12, 1997 |
| 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.
