The following data is part of a premarket notification filed by Alafair Biosciences Inc with the FDA for Versawrap Tendon Protector.
| Device ID | K160364 |
| 510k Number | K160364 |
| Device Name: | VersaWrap Tendon Protector |
| Classification | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon |
| Applicant | Alafair Biosciences Inc 3925 W. Braker Lane, Floor #3 Austin, TX 78759 |
| Contact | Ben Walthall |
| Correspondent | Ben Walthall Alafair Biosciences Inc 3925 W. Braker Lane, Floor #3 Austin, TX 78759 |
| Product Code | OWW |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-09 |
| Decision Date | 2016-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B454VTP22010 | K160364 | 000 |