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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K232665
Device Name GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)
Applicant
Convatec
First Ave., Deeside Industrial Estate
Deeside
Flintshire,  GB CH5 2NU
Applicant Contact Kim Jones
Correspondent
Convatec
First Ave., Deeside Industrial Estate
Deeside
Flintshire,  GB CH5 2NU
Correspondent Contact Kim Jones
Regulation Number876.5130
Classification Product Code
EZD  
Date Received08/31/2023
Decision Date 01/25/2024
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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