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510(k) K970674

G.E.M. WATER SYSTEMS, INTERNATIONAL by G.E.M. Water Systems — Product Code FIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1997
Date Received
February 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tank, Holding, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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