K950403 is an FDA 510(k) clearance for the SURGICAL SAW BLADES, a Blade, Saw, General & Plastic Surgery, Surgical (Class I — General Controls, product code GFA), submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on February 21, 1995, 21 days after receiving the submission on January 31, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K950403 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 31, 1995 |
| Decision Date | February 21, 1995 |
| Days to Decision | 21 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 |