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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
Applicant
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Applicant Contact BRUCE A MACFARLANE
Correspondent
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Correspondent 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 (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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