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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 K121092
Model IM2006, IM2009, IM2012
Device Name FLOWEASE [SUBCUTANEOUS] INFUSION SET
Original Applicant
BAXTER HEALTHCARE CORP.
one baxter way
westlake village,  CA  91362
Original Contact niedre m heckman
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/10/2012
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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