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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonic Irrigation System
510(k) Number K071057
Device Name COLONIC & ENEMA NOZZLE
Applicant
Tiller Mind Body, Inc.
42 E. Whisters Bend Circle
The Woodlands,  TX  77384
Applicant Contact HAROLD L JONES
Correspondent
Tiller Mind Body, Inc.
42 E. Whisters Bend Circle
The Woodlands,  TX  77384
Correspondent Contact HAROLD L JONES
Regulation Number876.5220
Classification Product Code
KPL  
Date Received04/16/2007
Decision Date 10/05/2007
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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