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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tank, holding, dialysis
510(k) Number K051031
Device Name AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
Applicant
AMERIWATER
1257 STANLEY AVE.
DAYTON,  OH  45404
Applicant Contact BRIAN R BOWMAN
Correspondent
AMERIWATER
1257 STANLEY AVE.
DAYTON,  OH  45404
Correspondent Contact BRIAN R BOWMAN
Regulation Number876.5820
Classification Product Code
FIN  
Date Received04/22/2005
Decision Date 01/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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