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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K981624
Device Name FLO-THRU
Applicant
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114 -1024
Applicant Contact D.E. GARDNER
Correspondent
Bio-Vascular, Inc.
2575 University Ave.
St. Paul,  MN  55114 -1024
Correspondent Contact D.E. GARDNER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received05/07/1998
Decision Date 08/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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