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510(k) K121421

FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) by Fresenius Medical Care North America, Design Cente — Product Code ONW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 17, 2013
Date Received: May 14, 2012
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hemodialysis System For Home Use
Device Class: Class II
Regulation Number: 876.5860
Review Panel: GU
Submission Type

To treat and provide hemodialysis therapy at home for chronic renal failure patients.