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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 K201776
Device Name Foley Balloon Catheter for Urology
Applicant
Apollon Co., Ltd.
M-1804/3203, 32, Songdogwahak-Ro, Yeonsu-Gu
Incheon,  KR 21984
Applicant Contact Donghyuk Shin
Correspondent
Tsd Life Sciences Co., Ltd.
211, Mallijae-Ro, Jung-Gu
Seoul,  KR 04508
Correspondent Contact Hyeyoung Moon
Regulation Number876.5130
Classification Product Code
EZL  
Date Received06/29/2020
Decision Date 12/30/2020
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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