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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 K983162
Device Name PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
Applicant
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Applicant Contact DIANNA L GECK
Correspondent
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Correspondent Contact DIANNA L GECK
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OXB  
Date Received09/10/1998
Decision Date 10/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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