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510(k) Data Aggregation
K Number
K094022Device Name
THE WATER LILY
Manufacturer
CLEARWATER PRODUCTS, LLC
Date Cleared
2010-06-11
(163 days)
Product Code
KPL, DEV
Regulation Number
876.5220Why did this record match?
Applicant Name (Manufacturer) :
CLEARWATER PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Water Lily The is indicated for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
Device Description
The Water Lily 10 is a professional colon hydrotherapy system for use when medically indicated. It introduces filtered water at a comfortable temperature into the large intestine, thus cleansing the colon of its contents. Water temperature is controlled by means of a mixing valve; flow is controlled by one switch operated by the user. The system is manually sanitized prior to each use with a suitable broad spectrum disinfectant (not included). The system includes disposable tubing and a sterile, disposable rectal nozzle intended for single use only (ConMed Corporation K050992).
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