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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 K121613
Device Name AGILIA INFUSION SYSTEM
Applicant
FRESENIUS KABI AG
THREE CORPORATE DRIVE
LAKE ZURICH,  IL  60047
Applicant Contact CHERYL ROSCHER
Correspondent
FRESENIUS KABI AG
THREE CORPORATE DRIVE
LAKE ZURICH,  IL  60047
Correspondent Contact CHERYL ROSCHER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/01/2012
Decision Date 05/01/2013
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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