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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Single Patient
510(k) Number K021060
Device Name FRESENIUS ICARE MONITORING SYSTEM
Applicant
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420 -9192
Applicant Contact NICHOLE RIEK
Correspondent
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420 -9192
Correspondent Contact NICHOLE RIEK
Regulation Number876.5820
Classification Product Code
FKP  
Date Received04/02/2002
Decision Date 11/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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