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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Subsystem, Water Purification
510(k) Number K944493
Device Name REVERSE OSMOSIS SYSTEM
Applicant
G.E.M. Water Systems
5940 Lakeshore Dr.
Cypress,  CA  90630
Applicant Contact JACK ENKOWITZ
Correspondent
G.E.M. Water Systems
5940 Lakeshore Dr.
Cypress,  CA  90630
Correspondent Contact JACK ENKOWITZ
Regulation Number876.5665
Classification Product Code
FIP  
Date Received09/13/1994
Decision Date 02/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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