FDA 510(k) Application Details - K984587

Device Classification Name	Alloy, Other Noble Metal   More FDA Info for this Device
510(K) Number	K984587
Device Name	Alloy, Other Noble Metal
Applicant	J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. ARMONK, NY 10504 US Other 510(k) Applications for this Company
Contact	TRIDIB DASGUPTA Other 510(k) Applications for this Contact
Regulation Number	872.3060   More FDA Info for this Regulation Number
Classification Product Code	EJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/24/1998
Decision Date	03/17/1999
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