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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemodialysis System For Home Use
510(k) Number K121421
Device Name FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
Applicant
Fresenius Medical Care North America, Design Cente
920 Winter St.
Waltham,  MA  01854
Applicant Contact COLLEEN DURRAN
Correspondent
Fresenius Medical Care North America, Design Cente
920 Winter St.
Waltham,  MA  01854
Correspondent Contact COLLEEN DURRAN
Regulation Number876.5860
Classification Product Code
ONW  
Subsequent Product Codes
KDI   ODX  
Date Received05/14/2012
Decision Date 01/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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