FDA 510(k) Application Details - K160166

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K160166
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	DE GOTZEN S.R.L. VIA ROMA, 45 OLGIATE OLONA, 21057 IT Other 510(k) Applications for this Company
Contact	Olivier Balouka Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2016
Decision Date	11/15/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review