FDA 510(k) Application Details - K101346

Device Classification Name	Saliva, Artificial   More FDA Info for this Device
510(K) Number	K101346
Device Name	Saliva, Artificial
Applicant	GC AMERICA, INC. 3737 W. 127TH ST. ALSIP, IL 60803 US Other 510(k) Applications for this Company
Contact	MARK HEISS Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LFD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2010
Decision Date	01/27/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review