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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 K182463
Device Name Silicone Foley Catheter
Applicant
Biosensors International Pte, Ltd.
36 Jalan Tukang
Singapore,  SG 619266
Applicant Contact Lor Yen Yin
Correspondent
Biosensors International Pte, Ltd.
36 Jalan Tukang
Singapore,  SG 619266
Correspondent Contact Jane Chen
Regulation Number876.5130
Classification Product Code
EZL  
Date Received09/10/2018
Decision Date 11/06/2019
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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