The following data is part of a premarket notification filed by Hand Biomechanics Lab, Inc. with the FDA for Agee-wristjack Fracture Reaction System (sterile Version), Model Cfd-147.
| Device ID | K984442 |
| 510k Number | K984442 |
| Device Name: | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 |
| Classification | Component, Traction, Invasive |
| Applicant | HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 Sacramento, CA 95825 |
| Contact | Timothy Stallings |
| Correspondent | Timothy Stallings HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 Sacramento, CA 95825 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-14 |
| Decision Date | 1999-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861994000205 | K984442 | 000 |