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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 K111740
Device Name AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
Applicant
AMERIWATER
1303 STANLEY AVE.
DAYTON,  OH  45404
Applicant Contact BRIAN R BOWMAN
Correspondent
AMERIWATER
1303 STANLEY AVE.
DAYTON,  OH  45404
Correspondent Contact BRIAN R BOWMAN
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/21/2011
Decision Date 10/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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