FDA 510(k) Application Details - K012514

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K012514
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	TROPHY RADIOLOGIE 4 RUE F. PELLOUTIER CROISSY-BEAUBOURG MARNE LA VALLEE CEDEX 2 77437 FR Other 510(k) Applications for this Company
Contact	MARIE-PIERRE LABAT-CAMY 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	08/06/2001
Decision Date	12/21/2001
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	N
Expedited Review