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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 K883696
Device Name FLO-RESTER
Applicant
Bio-Vascular, Inc.
2670 Patton Rd.
St. Paul,  MN  55113
Applicant Contact SHERRY A KRATTLEY
Correspondent
Bio-Vascular, Inc.
2670 Patton Rd.
St. Paul,  MN  55113
Correspondent Contact SHERRY A KRATTLEY
Regulation Number870.4450
Classification Product Code
DXC  
Date Received08/30/1988
Decision Date 11/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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