K895739 is an FDA 510(k) clearance for the MICROMEDICS SURGICAL DRILL SYSTEM. This device is classified as a Motor, Drill, Pneumatic (Class II - Special Controls, product code HBB).
Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on October 13, 1989, 17 days after receiving the submission on September 26, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4370.
| 510(k) Number | K895739 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 1989 |
| Decision Date | October 13, 1989 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HBB — Motor, Drill, Pneumatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4370 |