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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 K863720
Device Name HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES
Applicant
Water Pure, Inc.
507 Brandon Rd.
Louisville,  KY  40207
Applicant Contact WATHEN, M.D.
Correspondent
Water Pure, Inc.
507 Brandon Rd.
Louisville,  KY  40207
Correspondent Contact WATHEN, M.D.
Regulation Number876.5665
Classification Product Code
FIP  
Date Received09/23/1986
Decision Date 10/29/1986
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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