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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K142596
Device Name Infusomat Space Volumetric Infusion Pump
Applicant
B. Braun Medical Inc.
901 Marcon Boulevard
Allentown,  PA  18109
Applicant Contact Gary Johnson
Correspondent
B. Braun Medical Inc.
901 Marcon Boulevard
Allentown,  PA  18109
Correspondent Contact Gary Johnson
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/15/2014
Decision Date 06/18/2015
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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