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510(k) K171099

EON Portable Reverse Osmosis Water Purification System by Cantel — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2018
Date Received
April 13, 2017
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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