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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 K102892
Device Name ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
Applicant
AQUA SCIENCES, INC.
565 FILLMORE AVENUE
TONAWANDA,  NY  14150
Applicant Contact MICHAEL J TODD
Correspondent
AQUA SCIENCES, INC.
565 FILLMORE AVENUE
TONAWANDA,  NY  14150
Correspondent Contact MICHAEL J TODD
Regulation Number876.5665
Classification Product Code
FIP  
Date Received09/30/2010
Decision Date 02/03/2011
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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