FDA 510(k) Application Details - K033434

Device Classification Name	Alloy, Amalgam   More FDA Info for this Device
510(K) Number	K033434
Device Name	Alloy, Amalgam
Applicant	WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD. 1733 CANTON LN. MARIETTA, GA 30062 US Other 510(k) Applications for this Company
Contact	RONALD D ARKIN Other 510(k) Applications for this Contact
Regulation Number	872.3070   More FDA Info for this Regulation Number
Classification Product Code	EJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2003
Decision Date	11/12/2003
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	Y
Expedited Review