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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, urethral
510(k) Number K181206
Device Name GentleCath Glide Intermittent Urinary Catheter
Applicant
ConvaTec Limited
GDC, First Avenue, Deepside Industrial Park
Deeside,  GB CH5 2NU
Applicant Contact Elinor Jones
Correspondent
ConvaTec Limited
GDC, First Avenue, Deepside Industrial Park
Deeside,  GB CH5 2NU
Correspondent Contact Elinor Jones
Regulation Number876.5130
Classification Product Code
GBM  
Date Received05/07/2018
Decision Date 08/16/2018
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
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