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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 K094022
Device Name THE WATER LILY
Applicant
Clearwater Products, LLC
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Clearwater Products, LLC
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number876.5220
Classification Product Code
KPL  
Date Received12/30/2009
Decision Date 06/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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