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FDA 510(k) Application Details - K153084
Device Classification Name
System, Water Purification, General Medical Use
More FDA Info for this Device
510(K) Number
K153084
Device Name
System, Water Purification, General Medical Use
Applicant
NEPHROS INC.
41 GRAND AVE
River Edge, NJ 07661 US
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Contact
JAMES SUMMERTON
Other 510(k) Applications for this Contact
Regulation Number
876.5665
More FDA Info for this Regulation Number
Classification Product Code
NHV
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More FDA Info for this Product Code
Date Received
10/26/2015
Decision Date
04/08/2016
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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