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510(k) K954928

PORTABLE REVERSE OSMOSIS MACHINE by Better Water, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1996
Date Received
October 26, 1995
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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  • K920186 — WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (June 13, 1995)

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