FDA 510(k) Application Details - K002810

Device Classification Name	Alloy, Amalgam   More FDA Info for this Device
510(K) Number	K002810
Device Name	Alloy, Amalgam
Applicant	NORDISKA DENTAL AB P.O. BOX 435 LYNWOOD, WA 98046 US Other 510(k) Applications for this Company
Contact	RICHARD KIRSCHNER Other 510(k) Applications for this Contact
Regulation Number	872.3070   More FDA Info for this Regulation Number
Classification Product Code	EJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2000
Decision Date	10/31/2000
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