Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K200311 |
Device Name |
VersaWrap Tendon Protector |
Applicant |
Alafair Biosciences Inc |
6101 W Courtyard Drive ste 2-225 |
Austin,
TX
78730
|
|
Applicant Contact |
Ben Walthall |
Correspondent |
NAMSA |
400 Highway 169 South, Ste 500 |
Minneapolis,
MN
55426
|
|
Correspondent Contact |
Angela Mallery |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 02/06/2020 |
Decision Date | 03/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|