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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 K140953
Device Name GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER
Applicant
Convatec, Ltd.
Unit 20, First Ave., Deeside Industrial Park
Deeside,  GB CH5 2NU
Applicant Contact CLARE WILLIAMSON
Correspondent
Convatec, Ltd.
Unit 20, First Ave., Deeside Industrial Park
Deeside,  GB CH5 2NU
Correspondent Contact CLARE WILLIAMSON
Regulation Number876.5130
Classification Product Code
KOD  
Date Received04/14/2014
Decision Date 08/01/2014
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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