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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 K942867
Device Name CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
Applicant
Clearwater Colon Hydrotherapy, Inc.
3130 Thomas Rd.
Clearwater,  FL  34619
Applicant Contact MARY RUTH BAKER
Correspondent
Clearwater Colon Hydrotherapy, Inc.
3130 Thomas Rd.
Clearwater,  FL  34619
Correspondent Contact MARY RUTH BAKER
Regulation Number876.5220
Classification Product Code
KPL  
Date Received06/17/1994
Decision Date 06/26/1996
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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