FDA 510(k) Application Details - K181839

Device Classification Name	Saliva, Artificial   More FDA Info for this Device
510(K) Number	K181839
Device Name	Saliva, Artificial
Applicant	OraLabs, Inc. 18685 East Plaza Drive Parker, CO 80134 US Other 510(k) Applications for this Company
Contact	Gary Schlatter 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	07/11/2018
Decision Date	11/21/2019
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