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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, i.v. fluid transfer
510(k) Number K151423
Device Name APEX Compounding System Transfer Set
Applicant
B. BRAUN MEDICAL INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109
Applicant Contact TRACY MADDOCK
Correspondent
B. BRAUN MEDICAL INC.
901 MARCON BLVD.
ALLENTOWN,  PA  18109
Correspondent Contact TRACY MADDOCK
Regulation Number880.5440
Classification Product Code
LHI  
Subsequent Product Code
NEP  
Date Received05/28/2015
Decision Date 02/19/2016
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
Recalls CDRH Recalls
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