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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Irrigation, Urological
510(k) Number K023808
Device Name IRRIGATION SETS
Applicant
International Medsurg Connection
P.O.Box 848
Grayslake,  IL  60030
Applicant Contact MICHELE H VOVOLKA
Correspondent
International Medsurg Connection
P.O.Box 848
Grayslake,  IL  60030
Correspondent Contact MICHELE H VOVOLKA
Regulation Number876.5130
Classification Product Code
LJH  
Subsequent Product Code
HRX  
Date Received11/14/2002
Decision Date 03/10/2003
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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