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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
Applicant Contact BARBARA ATZENHOEFER
Correspondent
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114
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
Predetermined Change
Control Plan Authorized		 No
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