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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 K060942
Device Name WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
Applicant
Bob J. Johnson & Associates
16420 W. Hardy Rd., Suite 100
Houston,  TX  77060
Applicant Contact JON HULSEY
Correspondent
Bob J. Johnson & Associates
16420 W. Hardy Rd., Suite 100
Houston,  TX  77060
Correspondent Contact JON HULSEY
Regulation Number876.5665
Classification Product Code
FIP  
Date Received04/06/2006
Decision Date 07/07/2006
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
Predetermined Change
Control Plan Authorized		 No
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