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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 K072158
Device Name AQUA PURE DEIONIZER EXCHANGE SERVICE
Applicant
STAUBACH BARROR WATER SYSTEMS, INC.
495 ROTTERDAM IND. PARK
SCHENECTADY,  NY  12306
Applicant Contact JARROD J STAUBACH
Correspondent
STAUBACH BARROR WATER SYSTEMS, INC.
495 ROTTERDAM IND. PARK
SCHENECTADY,  NY  12306
Correspondent Contact JARROD J STAUBACH
Regulation Number876.5665
Classification Product Code
FIP  
Date Received08/03/2007
Decision Date 02/21/2008
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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