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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 K915258
Device Name SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM
Applicant
Aqua-Med Systems, Inc.
3607 Chapel Hill Rd., Suite M
Mchenry,  IL  60050
Applicant Contact THOMAS W HUEMANN
Correspondent
Aqua-Med Systems, Inc.
3607 Chapel Hill Rd., Suite M
Mchenry,  IL  60050
Correspondent Contact THOMAS W HUEMANN
Regulation Number876.5665
Classification Product Code
FIP  
Date Received11/19/1991
Decision Date 07/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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