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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intracardiac Patch Or Pledget, Biologically Derived
510(k) Number K221029
Device Name PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
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 Number870.3470
Classification Product Code
PSQ  
Date Received04/07/2022
Decision Date 10/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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