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510(k) K944493

REVERSE OSMOSIS SYSTEM by G.E.M. Water Systems — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1996
Date Received
September 13, 1994
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

Other clearances by G.E.M. Water Systems

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