FDA 510(k) Application Details - K123381

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K123381
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	CEFLA S.C. 110 E. GRANADA BLVD. SUITE 207 ORMOND BEACH, FL 32176 US Other 510(k) Applications for this Company
Contact	BERTHOIN CLAUDE 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	11/01/2012
Decision Date	05/10/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review