The following data is part of a premarket notification filed by Hand Biomechanics Lab, Inc. with the FDA for Wristjack System (remanufactured), Sterile And Non-sterile, Models Cfd-147-rs, Cfd-247-rns.
| Device ID | K030519 |
| 510k Number | K030519 |
| Device Name: | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS |
| Classification | Component, Traction, Invasive |
| Applicant | HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 Sacramento, CA 95825 |
| Contact | Timothy R Stallings |
| Correspondent | Timothy R 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 | 2003-02-19 |
| Decision Date | 2003-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861994000236 | K030519 | 000 |