FDA 510(k) Application Details - K001481

Device Classification Name	Alloy, Gold-Based Noble Metal   More FDA Info for this Device
510(K) Number	K001481
Device Name	Alloy, Gold-Based Noble Metal
Applicant	AUREX SA (PTY) LTD. 24 PLANTATION ROAD, EASTLEIGH EDENVALE, GAUTENG 1610 ZA Other 510(k) Applications for this Company
Contact	J. D DAVIS Other 510(k) Applications for this Contact
Regulation Number	872.3060   More FDA Info for this Regulation Number
Classification Product Code	EJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2000
Decision Date	06/23/2000
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