FDA 510(k) Application Details - K063773

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K063773
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	INSTRUMENTARIUM DENTAL INC. 300 WEST EDGERTON AVE. MILWAUKEE, WI 53207-6025 US Other 510(k) Applications for this Company
Contact	FRANK KASHINSKI 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	12/21/2006
Decision Date	01/31/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review