K934583 is an FDA 510(k) clearance for the BURRS, a Bur, Surgical, General & Plastic Surgery (Class I — General Controls, product code GFF), submitted by American Medical Specialties, Inc. (Roswell, US). The FDA issued a Cleared decision on January 26, 1994, 125 days after receiving the submission on September 23, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K934583 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 1993 |
| Decision Date | January 26, 1994 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GFF — Bur, Surgical, General & Plastic Surgery |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4820 |