Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K223052 |
Device Name |
Peri-Guard and Supple Peri-Guard |
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 | 09/29/2022 |
Decision Date | 04/07/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|