FDA 510(k) Application Details - K981693

Device Classification Name	Saliva, Artificial   More FDA Info for this Device
510(K) Number	K981693
Device Name	Saliva, Artificial
Applicant	GEBAUER CO. 9410 ST. CATHERINE AVE. CLEVELAND, OH 44104 US Other 510(k) Applications for this Company
Contact	DENISE E SPELLMAN 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	05/13/1998
Decision Date	08/06/2001
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