K933516 is an FDA 510(k) clearance for the ACU-E PUNCH. This device is classified as a Punch, Surgical (Class I — General Controls, product code LRY).
Submitted by Acuderm, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on March 24, 1994, 247 days after receiving the submission on July 20, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K933516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1993 |
| Decision Date | March 24, 1994 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | LRY — Punch, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |