K936186 is an FDA 510(k) clearance for the AESCULAP SKIN GRAFT MESHER. This device is classified as a Expander, Surgical, Skin Graft (Class I - General Controls, product code FZW).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on March 10, 1994, 77 days after receiving the submission on December 23, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K936186 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1993 |
| Decision Date | March 10, 1994 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZW — Expander, Surgical, Skin Graft |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |