FDA 510(k) Application Details - K110839

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K110839
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	SOREDEX PALODEX GROUP OY NAHKELANTIE 160 TUUSULA FIN-04300 FI Other 510(k) Applications for this Company
Contact	MATTI TULIKOURA 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	03/25/2011
Decision Date	06/30/2011
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