K950449 is an FDA 510(k) clearance for the SURGICAL BUR, a Bur, Surgical, General & Plastic Surgery (Class I — General Controls, product code GFF), submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on March 1, 1995, 26 days after receiving the submission on February 3, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K950449 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 03, 1995 |
| Decision Date | March 01, 1995 |
| Days to Decision | 26 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 |