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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, Pca
510(k) Number K143612
Device Name LifeCare PCA Infusion System
Applicant
Hospira, Inc.
275 N. Field Dr.
Lake Forest,  IL  60045
Applicant Contact Tom Gutierrez
Correspondent
Hospira, Inc.
275 N. Field Dr.
Lake Forest,  IL  60045
Correspondent Contact Yuliya Matlin
Regulation Number880.5725
Classification Product Code
MEA  
Subsequent Product Code
FPA  
Date Received12/19/2014
Decision Date 04/08/2016
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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