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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 K092481
Device Name HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
Applicant
NEW AQUA LLC (DBA AQUA SYSTEMS)
114 VISTA PARKWAY
AVON,  IN  46123
Applicant Contact NEVIN RUDIE
Correspondent
NEW AQUA LLC (DBA AQUA SYSTEMS)
114 VISTA PARKWAY
AVON,  IN  46123
Correspondent Contact NEVIN RUDIE
Regulation Number876.5665
Classification Product Code
FIP  
Date Received08/13/2009
Decision Date 04/02/2010
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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