Device Classification Name |
mesh, surgical, absorbable, orthopaedics, reinforcement of tendon
|
510(k) Number |
K230316 |
Device Name |
FlexBand; FlexPatch; FlexBand Plus |
Applicant |
International Life Sciences |
2150 Northwest Parkway SE Suite G |
Marietta,
GA
30076
|
|
Applicant Contact |
Tiffini Wittwer |
Correspondent |
International Life Sciences |
2150 Northwest Parkway SE Suite G |
Marietta,
GA
30076
|
|
Correspondent Contact |
Tiffini Wittwer |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/06/2023 |
Decision Date | 05/26/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|