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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, retention type, balloon
510(k) Number K911617
Device Name UROTECH CATHETER
Applicant
UROTECH U.S.A., INC.
139 NASSAU BLVD.
GARDEN CITY,  NY  11530
Applicant Contact CAROZZA
Correspondent
UROTECH U.S.A., INC.
139 NASSAU BLVD.
GARDEN CITY,  NY  11530
Correspondent Contact CAROZZA
Regulation Number876.5130
Classification Product Code
EZL  
Date Received04/11/1991
Decision Date 02/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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