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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 K955585
Device Name V2 INJECTION SITE
Original Applicant
B. BRAUN MEDICAL, INC.
824 twelfth ave.
bethlehem,  PA  18018
Original Contact mark s alsberge
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/07/1995
Decision Date 05/15/1996
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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