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FDA 510(k) Applications Submitted by FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K121421
05/14/2012
FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
K120505
02/21/2012
FRESENIUS 2008T HEMODIALYSIS MACHINE
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
K120823
03/19/2012
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
K123630
11/23/2012
FRESENIUS LIBERTY CYCLER
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
K101715
06/18/2010
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
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