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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 K123630
Device Name FRESENIUS LIBERTY CYCLER
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
920 WINTER ST
WALTHAM,  MA  02451
Applicant Contact DENISE OPPERMANN
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
920 WINTER ST
WALTHAM,  MA  02451
Correspondent Contact DENISE OPPERMANN
Regulation Number876.5630
Classification Product Code
FKX  
Date Received11/23/2012
Decision Date 09/09/2013
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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