FDA 510(k) Application Details - K000981

Device Classification Name	Alloy, Metal, Base   More FDA Info for this Device
510(K) Number	K000981
Device Name	Alloy, Metal, Base
Applicant	C-MIX 3234 ELLA LN. NEW PORT RICHEY, FL 34655 US Other 510(k) Applications for this Company
Contact	ART WARD Other 510(k) Applications for this Contact
Regulation Number	872.3710   More FDA Info for this Regulation Number
Classification Product Code	EJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2000
Decision Date	06/13/2000
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