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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 K232469
Device Name Rüsch Latex Gold Foley Catheter
Applicant
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Suite 600n
Morrisville,  NC  27560
Applicant Contact Angela Bouse
Correspondent
Teleflexmedical, Inc.
3015 Carrington Mill Blvd.
Suite 600n
Morrisville,  NC  27560
Correspondent Contact Angela Bouse
Regulation Number876.5130
Classification Product Code
EZL  
Date Received08/15/2023
Decision Date 08/01/2024
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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