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510(k) K161304

EndoPur Filter by Nephros, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2017
Date Received
May 10, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type

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