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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, urological
510(k) Number K901738
Device Name SELFCATH
Original Applicant
269 portage rd.
lewiston,  NY  14092
Original Contact william g stewart
Regulation Number876.5130
Classification Product Code
Date Received04/17/1990
Decision Date 06/27/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No