FDA 510(k) Application Details - K071484

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K071484
Device Name	Cement, Dental
Applicant	GLUSTITCH, INC. #307 7188 PROGRESS WAY DELTA, B.C. V4G 1M6 CA Other 510(k) Applications for this Company
Contact	DON BLACKLOCK Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2007
Decision Date	10/10/2007
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