SPECTRUM DESIGNS SPECTRAGEL
Device Facts
| Record ID | K970702 |
|---|---|
| Device Name | SPECTRUM DESIGNS SPECTRAGEL |
| Applicant | Spectrum Designs, Inc. |
| Product Code | MDA · General, Plastic Surgery |
| Decision Date | May 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.
