FDA 510(k) Application Details - K140013

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K140013
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	SOPRO - ACTEON GROUP 124 GAITHER DRIVE SUITE #140 MT. LAUREL, NJ 08055 US Other 510(k) Applications for this Company
Contact	RICK ROSATI Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	MUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2014
Decision Date	09/05/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review