FDA 510(k) Application Details - K070697

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K070697
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	GC AMERICA, INC. 3737 WEST 127TH ST. ALSIP, IL 60803 US Other 510(k) Applications for this Company
Contact	TERRY L JORITZ-LYONS Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2007
Decision Date	03/29/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review