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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K073538
Device Name DUAL CHAMBER TPN CONTAINER
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 Number880.5025
Classification Product Code
KPE  
Date Received12/17/2007
Decision Date 03/12/2008
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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