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 |