K965256 is an FDA 510(k) clearance for the DMS-1000C DERMOABRADER, a Dermatome (Class I — General Controls, product code GFD), submitted by Mattioli Engineering, Srl (Florence, IT). The FDA issued a Cleared decision on December 9, 1996, 115 days after receiving the submission on August 16, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K965256 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 1996 |
| Decision Date | December 09, 1996 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GFD — Dermatome |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4820 |