The following data is part of a premarket notification filed by Hand Biomechanics Lab, Inc with the FDA for Hbl Blade Assembly.
| Device ID | K222490 |
| 510k Number | K222490 |
| Device Name: | HBL Blade Assembly |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-17 |
| Decision Date | 2022-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861994000281 | K222490 | 000 |