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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
Device Name SYMBIQ INFUSION AND ADMINSTRATION SET
Applicant
Hospira, Inc.
275 N. Field Dr.
Lake Forest,  IL  60045
Applicant Contact Ray Silkaitis
Correspondent
Hospira, Inc.
275 N. Field Dr.
Lake Forest,  IL  60045
Correspondent 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 (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
Recalls CDRH Recalls
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