K972597 is an FDA 510(k) clearance for the PMT NEW BEGINNINGS GELSHAPES & AMEND, a Elastomer, Silicone, For Scar Management (Class I — General Controls, product code MDA), submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on October 1, 1997, 82 days after receiving the submission on July 11, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K972597 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 11, 1997 |
| Decision Date | October 01, 1997 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MDA — Elastomer, Silicone, For Scar Management |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4025 |