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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Peritoneal, Automatic Delivery
510(k) Number K002892
FOIA Releasable 510(k) K002892
Device Name FRSENIUS PD IQCARD CYCLER
Applicant
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420
Applicant Contact ARTHUR EILINSFEILD
Correspondent
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420
Correspondent Contact ARTHUR EILINSFEILD
Regulation Number876.5630
Classification Product Code
FKX  
Date Received09/15/2000
Decision Date 04/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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