The following data is part of a premarket notification filed by Alafair Biosciences Inc with the FDA for Versawrap Tendon Protector.
| Device ID | K200311 |
| 510k Number | K200311 |
| Device Name: | VersaWrap Tendon Protector |
| Classification | Mesh, Surgical |
| Applicant | Alafair Biosciences Inc 6101 W Courtyard Drive Ste 2-225 Austin, TX 78730 |
| Contact | Ben Walthall |
| Correspondent | Angela Mallery NAMSA 400 Highway 169 South, Ste 500 Minneapolis, MN 55426 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-06 |
| Decision Date | 2020-03-06 |