FDA 510(k) Application Details - K063121

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K063121
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	GENORAY CO., LTD. 340 SHADY GROVE ROAD FLINTVILLE, TN 37335 US Other 510(k) Applications for this Company
Contact	CHARLIE MACK 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	10/12/2006
Decision Date	01/11/2007
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	Y
Expedited Review