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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
Applicant Contact BRUCE A MACFARLANE
Correspondent
BIO-VASCULAR, INC.
2670 PATTON RD.
SAINT PAUL,  MN  55113
Correspondent Contact BRUCE A MACFARLANE
Regulation Number878.3300
Classification Product Code
FTM  
Date Received05/27/1992
Decision Date 12/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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