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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 K000388
Device Name CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
Applicant
CLEARWATER COLON HYDROTHERAPY, INC.
4451-A SOUTH PINE AVE.
OCALA,  FL  34480
Applicant Contact STUART K BAKER
Correspondent
CLEARWATER COLON HYDROTHERAPY, INC.
4451-A SOUTH PINE AVE.
OCALA,  FL  34480
Correspondent Contact STUART K BAKER
Regulation Number876.5220
Classification Product Code
KPL  
Date Received02/07/2000
Decision Date 08/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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