K960630 is an FDA 510(k) clearance for the ANSPAHC SPEED REDUCER. This device is classified as a Motor, Drill, Pneumatic (Class II - Special Controls, product code HBB).
Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on November 19, 1996, 284 days after receiving the submission on February 9, 1996.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4370.
| 510(k) Number | K960630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1996 |
| Decision Date | November 19, 1996 |
| Days to Decision | 284 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HBB — Motor, Drill, Pneumatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4370 |