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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K911415
Device Name TRUMPET VALVE
Applicant
B. BRAUN OF AMERICA, INC.
824 TWELFTH AVE.
PO BOX 4027
BETHLEHEM,  PA  18018 -0027
Applicant Contact PEGGY KEIFFER
Correspondent
B. BRAUN OF AMERICA, INC.
824 TWELFTH AVE.
PO BOX 4027
BETHLEHEM,  PA  18018 -0027
Correspondent Contact PEGGY KEIFFER
Regulation Number880.5440
Classification Product Code
FMG  
Date Received04/01/1991
Decision Date 06/03/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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