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510(k) K161844

Matrix Pre-Treatment Controller by Better Water, LLC — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2016
Date Received
July 5, 2016
Clearance Type
Abbreviated
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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  • K920186 — WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (June 13, 1995)

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