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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 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 Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OXE  
Date Received09/27/2021
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
Predetermined Change
Control Plan Authorized		 No
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