FDA 510(k) Application Details - K180680

Device Classification Name	Saliva, Artificial   More FDA Info for this Device
510(K) Number	K180680
Device Name	Saliva, Artificial
Applicant	Laclede, Inc. 2103 E. University Dr. Rancho Dominguez, CA 90220 US Other 510(k) Applications for this Company
Contact	Michael Pellico 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	03/15/2018
Decision Date	10/11/2018
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