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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K842066
Device Name PERI-GUARD PERICARDIAL PATCH
Applicant
Genetic Laboratories, Inc.
1385 Dentennial Dr.
St. Paul,  MN  55113
Correspondent
Genetic Laboratories, Inc.
1385 Dentennial Dr.
St. Paul,  MN  55113
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received04/23/1984
Decision Date 12/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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