The following data is part of a premarket notification filed by Alafair Biosciences Inc with the FDA for Versawrap.
| Device ID | K213163 |
| 510k Number | K213163 |
| Device Name: | VersaWrap |
| Classification | Mesh, Surgical |
| Applicant | Alafair Biosciences Inc 6101 W Courtyard Drive Suite 2-225 Austin, TX 78730 |
| Contact | Angela Mallery |
| Correspondent | Angela Mallery Alafair Biosciences Inc 6101 W Courtyard Drive Suite 2-225 Austin, TX 78730 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-28 |
| Decision Date | 2021-10-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VERSAWRAP 97908304 not registered Live/Pending |
Prentke Romich Company 2023-04-26 |
![]() VERSAWRAP 97066007 not registered Live/Pending |
Techflex Inc. 2021-10-08 |
![]() VERSAWRAP 86553246 not registered Live/Pending |
Alafair Biosciences, Inc. 2015-03-04 |
![]() VERSAWRAP 85169347 4119315 Live/Registered |
CPG INTERNATIONAL LLC 2010-11-04 |
![]() VERSAWRAP 78063926 not registered Dead/Abandoned |
Soltech, Inc. 2001-05-16 |
![]() VERSAWRAP 73640672 1465468 Dead/Cancelled |
MINNESOTA DIVERSIFIED PRODUCTS, INC. 1987-01-20 |