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FDA 510(k) Application Details - K000388
Device Classification Name
Colonic Irrigation System
More FDA Info for this Device
510(K) Number
K000388
Device Name
Colonic Irrigation System
Applicant
CLEARWATER COLON HYDROTHERAPY, INC.
4451-A SOUTH PINE AVE.
OCALA, FL 34480 US
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Contact
STUART K BAKER
Other 510(k) Applications for this Contact
Regulation Number
876.5220
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Classification Product Code
KPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/07/2000
Decision Date
08/08/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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