FDA 510(k) Application Details - K081899

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K081899
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	E-WOO TECHNOLOGY CO., LTD. 256 NORTH SAM HOUSTON PKWY E. #115 HOUSTON, TX 77060 US Other 510(k) Applications for this Company
Contact	DAVE KIM Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	EHD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2008
Decision Date	08/21/2008
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	Y
Expedited Review