K964252 is an FDA 510(k) clearance for the ORTHOCHUCK, a Motor, Surgical Instrument, Ac-powered (Class I — General Controls, product code GEY), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on May 27, 1997, 215 days after receiving the submission on October 24, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K964252 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 24, 1996 |
| Decision Date | May 27, 1997 |
| Days to Decision | 215 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEY — Motor, Surgical Instrument, Ac-powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4820 |