K940208 is an FDA 510(k) clearance for the AESCULAP ACCU-DERMATOME. This device is classified as a Dermatome (Class I - General Controls, product code GFD).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on February 24, 1994, 41 days after receiving the submission on January 14, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K940208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1994 |
| Decision Date | February 24, 1994 |
| Days to Decision | 41 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 |