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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 K971048
Device Name PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
Applicant
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Applicant Contact BARBARA ATZENHOEFER
Correspondent
BIO-VASCULAR, INC.
2575 UNIVERSITY AVE.
ST. PAUL,  MN  55114 -1024
Correspondent Contact BARBARA ATZENHOEFER
Regulation Number878.3300
Classification Product Code
FTM  
Date Received03/21/1997
Decision Date 05/09/1997
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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