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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 K961811
Device Name PERI-GUARD PERICARDIUM
Original Applicant
BIO-VASCULAR, INC.
2575 university ave.
st. paul,  MN  55114 1024
Original Contact bruce a macfarlane
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OWV  
Date Received05/10/1996
Decision Date 06/13/1996
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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