FDA 510(k) Application Details - K081925

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K081925
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160 TUUSULA, FINLAND 04300 FI Other 510(k) Applications for this Company
Contact	JOUNI ONNELA 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	07/07/2008
Decision Date	09/02/2008
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