K934603 is an FDA 510(k) clearance for the SURGICAL SAW BLADES. This device is classified as a Blade, Saw, General & Plastic Surgery, Surgical (Class I - General Controls, product code GFA).
Submitted by American Medical Specialties, Inc. (Roswell, US). The FDA issued a Cleared decision on February 22, 1994, 151 days after receiving the submission on September 24, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K934603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1993 |
| Decision Date | February 22, 1994 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GFA — Blade, Saw, General & Plastic Surgery, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |