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FDA 510(k) Application Details - K131202
Device Classification Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
More FDA Info for this Device
510(K) Number
K131202
Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant
DIALYSIS MEDICAL SOLUTIONS, LLC
21 EAST STATE STREET
SUITE 1700
COLUMBUS, OH 43215 US
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Contact
COURTNEY J MILLER
Other 510(k) Applications for this Contact
Regulation Number
876.5820
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Classification Product Code
KPO
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More FDA Info for this Product Code
Date Received
04/29/2013
Decision Date
04/03/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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