FDA 510(k) Application Details - K172928

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K172928
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	Rolence Enterprise Inc. 18-3 Lane 231 Pu Chung Rd., Chungli Taoyuan 32083 TW Other 510(k) Applications for this Company
Contact	Sterling Cheng 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	09/25/2017
Decision Date	03/16/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review