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G.E.M. Water Systems
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K970674
G.E.M. WATER SYSTEMS, INTERNATIONAL
November 19, 1997
K944493
REVERSE OSMOSIS SYSTEM
February 20, 1996
K944492
DIALYZER REPROCESSING SYSTEM
August 28, 1995