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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 K940205
Device Name PERI-STRIPS
Original Applicant
BIO-VASCULAR, INC.
2670 patton rd.
saint paul,  MN  55113
Original Contact bruce a mcfarlane
Regulation Number878.3300
Classification Product Code
FTM  
Date Received01/14/1994
Decision Date 05/02/1994
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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