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FDA 510(k) Application Details - K161304
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
510(K) Number
K161304
Device Name
Subsystem, Water Purification
Applicant
Nephros Inc.
41 Grand Ave
River Edge, NJ 07661 US
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Contact
Hollie Johnson
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Regulation Number
876.5665
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Classification Product Code
FIP
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More FDA Info for this Product Code
Date Received
05/10/2016
Decision Date
03/02/2017
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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