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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 K923657
Device Name SUPPLE PERI-GUARD
Applicant
BIO-VASCULAR, INC.
2670 patton rd.
saint paul,  MN  55113
Contact bruce a macfarlane
Regulation Number878.3300
Classification Product Code
FTM  
Date Received05/27/1992
Decision Date 12/21/1992
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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