FDA 510(k) Application Details - K063459

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K063459
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	SOREDEX PALODEX GROUP OY NAHKELANTIE 160 TUUSULA 00430 FI Other 510(k) Applications for this Company
Contact	KAI LANER Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	MUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2006
Decision Date	12/26/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review