FDA 510(k) Application Details - K081913

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K081913
Device Name	Cement, Dental
Applicant	META BIOMED CO., LTD. 414-12 MO CHOONG DONG CHEUNG JU CITY, CHUNG BUK 441-12 KR Other 510(k) Applications for this Company
Contact	TAE-HOON KIM Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2008
Decision Date	09/05/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review