Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K213125 |
Device Name |
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology |
Applicant |
Synovis Life Technologies. Inc. (A Subsidiary Of Baxter |
International Inc.) |
2575 University Ave. W |
St. Paul,
MN
55114
|
|
Applicant Contact |
Megan Sajjad |
Correspondent |
Synovis Life Technologies. Inc. (A Subsidiary Of Baxter |
International Inc.) |
2575 University Ave. W |
St. Paul,
MN
55114
|
|
Correspondent Contact |
Megan Sajjad |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/27/2021 |
Decision Date | 10/27/2021 |
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
|