FDA 510(k) Application Details - K132378

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K132378
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	DE GOTZEN S.R.L. VIA ROMA 45 OLGIATE OLONA, VARESE 21057 IT Other 510(k) Applications for this Company
Contact	MAURIZIO DE GOTZEN 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	07/31/2013
Decision Date	05/30/2014
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