FDA 510(k) Application Details - K042860

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K042860
Device Name	Material, Impression
Applicant	HANDAE CHEMICAL CO., LTD. 560-24, SONGDU-RI, JINCHEON-UP JINCHEON-GUN,CHUNGCHEONGBUK-DO 365-802 KR Other 510(k) Applications for this Company
Contact	JAE HO YU Other 510(k) Applications for this Contact
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2004
Decision Date	12/03/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review