K931737 is an FDA 510(k) clearance for the HEDLEYL INTRAMEDULLARY PREPARATION BRUSH, a Instrument, Cutting, Orthopedic (Class I — General Controls, product code HTZ), submitted by Synvasive Technology, Inc. (Rancho Cordova, US). The FDA issued a Cleared decision on January 7, 1994, 275 days after receiving the submission on April 7, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K931737 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 07, 1993 |
| Decision Date | January 07, 1994 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HTZ — Instrument, Cutting, Orthopedic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |