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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 K894300
Device Name SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS
Applicant
U.S. Filter/Continental Water Systems
5405 Bandera Rd., Suite 101
San Antonio,  TX  78238
Applicant Contact LINDA STEWART
Correspondent
U.S. Filter/Continental Water Systems
5405 Bandera Rd., Suite 101
San Antonio,  TX  78238
Correspondent Contact LINDA STEWART
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/22/1989
Decision Date 03/13/1990
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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