FDA 510(k) Application Details - K012355

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K012355
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	TG GROUP, INC. 3505 LAIRD RD. UNIT 7 MISSISSAUGA, ONTARIO L5L 5Y7 CA Other 510(k) Applications for this Company
Contact	WAYNE LEBEAU 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	07/25/2001
Decision Date	08/09/2001
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	Y
Expedited Review