K945594 is an FDA 510(k) clearance for the DECA DERMATOME (MICROMOTOR SYSTEM), a Dermatome (Class I — General Controls, product code GFD), submitted by Depuy Intl., Ltd. (West Yorkshire, GB). The FDA issued a Cleared decision on June 5, 1995, 203 days after receiving the submission on November 14, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K945594 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 14, 1994 |
| Decision Date | June 05, 1995 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GFD — Dermatome |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4820 |