FDA 510(k) Application Details - K130109

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K130109
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	VILLA SISTEMI MEDICALI S.P.A. VIADELLE AZALEE, 5 BUCCINASCO, MILANO 20090 IT Other 510(k) Applications for this Company
Contact	PAOLO CASAGRANDE SANTIN 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	01/16/2013
Decision Date	08/01/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review