FDA 510(k) Application Details - K003603

Device Classification Name	Alloy, Gold-Based Noble Metal   More FDA Info for this Device
510(K) Number	K003603
Device Name	Alloy, Gold-Based Noble Metal
Applicant	JELENKO CO. 99 BUSINESS PARK DR. ARMONK, NY 10504 US Other 510(k) Applications for this Company
Contact	RAPHAEL JUDKINS 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	11/21/2000
Decision Date	01/10/2001
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