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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 K110901
Models 16026, 16027, MULTIPLE
Device Name SYMBIQ INFUSION AND ADMINSTRATION SET
Original Applicant
HOSPIRA, INC.
275 north field dr.
lake forest,  IL  60045
Original Contact ray silkaitis
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received03/31/2011
Decision Date 03/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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