FDA 510(k) Application Details - K201776

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K201776
Device Name	Catheter, Retention Type, Balloon
Applicant	Apollon co., Ltd. M-1804/3203, 32, Songdogwahak-ro, Yeonsu-gu Incheon 21984 KR Other 510(k) Applications for this Company
Contact	Donghyuk Shin Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2020
Decision Date	12/30/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review