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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 K870534
Device Name DOTOLO COLON HYDROTHERAPY INSTRUMENT
Applicant
Dotolo Research Corp. C/O Keller and Heckman
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Applicant Contact JOHN S ELDRED
Correspondent
Dotolo Research Corp. C/O Keller and Heckman
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Correspondent Contact JOHN S ELDRED
Regulation Number876.5220
Classification Product Code
KPL  
Date Received02/09/1987
Decision Date 06/18/1987
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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