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510(k) K920186

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS by Better Water, Inc. — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1995
Date Received
January 14, 1992
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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