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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 K003720
FOIA Releasable 510(k) K003720
Device Name ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
Applicant
Lifestream Purfication Systems, LLC
6401 Meadows W. Dr.
Fort Worth,  TX  76132
Applicant Contact RICHARD A HAMER
Correspondent
Lifestream Purfication Systems, LLC
7303 Burleson Rd., Suite 801
Austin,  TX  78744
Correspondent Contact Amy H Bruno
Regulation Number876.5220
Classification Product Code
KPL  
Date Received12/04/2000
Decision Date 06/27/2002
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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