PIP Fix
Component, Traction, Invasive
Hand Biomechanics Lab, Inc.
The following data is part of a premarket notification filed by Hand Biomechanics Lab, Inc. with the FDA for Pip Fix.
Pre-market Notification Details
| Device ID | K181192 |
| 510k Number | K181192 |
| Device Name: | PIP Fix |
| Classification | Component, Traction, Invasive |
| Applicant | Hand Biomechanics Lab, Inc. 77 Scripps Drive, Suite 104 Sacramento, CA 95825 |
| Contact | Dustin Dequine |
| Correspondent | Dustin Dequine Hand Biomechanics Lab, Inc. 77 Scripps Drive, 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 | 2018-05-04 |
| Decision Date | 2018-10-22 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861994000243 | K181192 | 000 |
Trademark Results [PIP Fix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PIP FIX 87837190 5758898 Live/Registered |
Hand Biomechanics Lab, Inc. 2018-03-16 |
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