FDA 510(k) Application Details - K183289

Device Classification Name	Snare, Flexible   More FDA Info for this Device
510(K) Number	K183289
Device Name	Snare, Flexible
Applicant	Finemedix Co., Ltd. 60, Maeyeo-ro, Dong-gu Daegu 41065 KR Other 510(k) Applications for this Company
Contact	Hee Kyung Kwon Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	FDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2018
Decision Date	03/06/2019
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