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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 K001282
Device Name AIW WATER SYSTEM FOR HEMODIALYSIS
Applicant
American Industrial Water
327 S. Hydraulic
Wichita,  KS  67211
Applicant Contact JOE GREENING
Correspondent
American Industrial Water
327 S. Hydraulic
Wichita,  KS  67211
Correspondent Contact JOE GREENING
Regulation Number876.5665
Classification Product Code
FIP  
Date Received04/21/2000
Decision Date 12/15/2000
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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