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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 K942988
Device Name FILTERED EXTENSION SETS
Original Applicant
B. BRAUN OF AMERICA, INC.
824 twelfth ave.
po box 4027
bethlehem,  PA  18018 0027
Original Contact mark s alsberge
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/20/1994
Decision Date 07/14/1995
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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