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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 K002102
Device Name GENTLE COLONICS IRRIGATION SYSTEM
Applicant
GENTLE COLONICS, INC.
3722 AVENUE SAUSALITO
IRVINE,  CA  92606 -1849
Applicant Contact GRACE HOLLAND
Correspondent
GENTLE COLONICS, INC.
3722 AVENUE SAUSALITO
IRVINE,  CA  92606 -1849
Correspondent Contact GRACE HOLLAND
Regulation Number876.5220
Classification Product Code
KPL  
Date Received07/12/2000
Decision Date 02/06/2002
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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