FDA 510(k) Application Details - K181690

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K181690
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
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	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2018
Decision Date	12/21/2018
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