FDA 510(k) Application Details - K152598

Device Classification Name	More FDA Info for this Device
510(K) Number	K152598
Device Name	Endo Keeper
Applicant	NELIS 1005,201-DOUG BUCHEON TECHNO PARL SSANGYONG3CHA SAMJEONG-DONG OJEONG-GU BUCHEON 421-742 KR Other 510(k) Applications for this Company
Contact	SEO OU NAM Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2015
Decision Date	03/17/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review