FDA 510(k) Application Details - K173157

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K173157
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	Good Doctors Co.,Ltd. #208, B-Dong, 283 Bupyeong-Daero, Bupyeong-Gu Incheon 21315 KR Other 510(k) Applications for this Company
Contact	Sungro Joo Other 510(k) Applications for this Contact
Regulation Number	872.6070   More FDA Info for this Regulation Number
Classification Product Code	EBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2017
Decision Date	05/29/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review