FDA 510(k) Application Details - K011628

Device Classification Name	Alloy, Gold-Based Noble Metal   More FDA Info for this Device
510(K) Number	K011628
Device Name	Alloy, Gold-Based Noble Metal
Applicant	GATEWAY ALLOYS, INC. 1702 SCHERER PKWY. ST. CHARLES, MO 63303 US Other 510(k) Applications for this Company
Contact	JOHN C CONSTANTINE 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	05/29/2001
Decision Date	07/16/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review