FDA 510(k) Application Details - K162850

Device Classification Name	More FDA Info for this Device
510(K) Number	K162850
Device Name	GuideMia Ortho+
Applicant	GUIDEMIA TECHNOLOGIES, LLC 5030 KATELLA AVE., STE 209 LOS ALAMITOS, CA 90720 US Other 510(k) Applications for this Company
Contact	FEI GAO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2016
Decision Date	03/24/2017
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