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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 K043363
Device Name FRESENIUS LIBERTY CYCLER
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
95 HAYDEN AVE.
LEXINGTON,  MA  02420 -9192
Applicant Contact ARTHUR EILINSFELD
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
95 HAYDEN AVE.
LEXINGTON,  MA  02420 -9192
Correspondent Contact ARTHUR EILINSFELD
Regulation Number876.5630
Classification Product Code
FKX  
Date Received12/07/2004
Decision Date 03/31/2005
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
Recalls CDRH Recalls
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