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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K974145
Device Name V3 VALVE
Applicant
B. Braun Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact MARK S ALSBERGE
Correspondent
B. Braun Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact MARK S ALSBERGE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/03/1997
Decision Date 01/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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