FDA 510(k) Application Details - K971292

Device Classification Name	Alloy, Gold-Based Noble Metal   More FDA Info for this Device
510(K) Number	K971292
Device Name	Alloy, Gold-Based 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	EJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/1997
Decision Date	05/20/1997
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