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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 K050992
Device Name CONMED IRRIGATION NOZZLE
Applicant
Conmedcorp
525 French Rd.
Utica,  NY  13502
Applicant Contact IRA DUESLER
Correspondent
Conmedcorp
525 French Rd.
Utica,  NY  13502
Correspondent Contact IRA DUESLER
Regulation Number876.5220
Classification Product Code
KPL  
Date Received04/19/2005
Decision Date 07/14/2005
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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