FDA 510(k) Application Details - K163705

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K163705
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	Vatech Co., Ltd 13, Samsung 1-ro 2-gil Hwaseong-si 18449 KR Other 510(k) Applications for this Company
Contact	Daniel Kim Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	EHD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2016
Decision Date	01/24/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review