K930409 is an FDA 510(k) clearance for the PMT(R) SILICONE GEL SHEETING MODEL 3505-1, 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 September 1, 1993, 218 days after receiving the submission on January 26, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K930409 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 26, 1993 |
| Decision Date | September 01, 1993 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MDA — Elastomer, Silicone, For Scar Management |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4025 |