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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 K983602
Device Name CV PERI-GUARD AND VASCU-GUARD
Applicant
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114 -1024
Applicant Contact DIANNA L GECK
Correspondent
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114 -1024
Correspondent Contact DIANNA L GECK
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received10/13/1998
Decision Date 11/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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