The following data is part of a premarket notification filed by Hand Biomechanics Lab, Inc. with the FDA for Agee-wristjack Pre-drill Kit.
| Device ID | K942906 |
| 510k Number | K942906 |
| Device Name: | AGEE-WRISTJACK PRE-DRILL KIT |
| Classification | Bit, Drill |
| Applicant | HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 Sacramento, CA 95825 |
| Contact | Tim Stallings |
| Correspondent | Tim Stallings HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 Sacramento, CA 95825 |
| Product Code | HTW |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-21 |
| Decision Date | 1994-12-22 |