FDA 510(k) Application Details - K073365

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K073365
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	VATECH CO., LTD. 30 NORTHPORT ROAD SOUND BEACH, NY 11789 US Other 510(k) Applications for this Company
Contact	STEPHEN T MLCOCH 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	11/30/2007
Decision Date	04/08/2008
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