K952702 is an FDA 510(k) clearance for the DERMA SEAL. This device is classified as a Strip, Adhesive, Closure, Skin (Class I - General Controls, product code FPX).
Submitted by Ttl Medical (Knoxville, US). The FDA issued a Cleared decision on June 28, 1995, 15 days after receiving the submission on June 13, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K952702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 1995 |
| Decision Date | June 28, 1995 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FPX — Strip, Adhesive, Closure, Skin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5240 |