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510(k) K944492

DIALYZER REPROCESSING SYSTEM by G.E.M. Water Systems — Product Code LIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1995
Date Received
September 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by G.E.M. Water Systems

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