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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
DXZ  
Date Received09/29/2022
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
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