K942906 is an FDA 510(k) clearance for the AGEE-WRISTJACK PRE-DRILL KIT. This device is classified as a Bit, Drill (Class I - General Controls, product code HTW).
Submitted by Hand Biomechanics Lab, Inc. (Sacramento, US). The FDA issued a Cleared decision on December 22, 1994, 184 days after receiving the submission on June 21, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K942906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1994 |
| Decision Date | December 22, 1994 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HTW - Bit, Drill |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |