FDA 510(k) Application Details - K181194

Device Classification Name	Saliva, Artificial   More FDA Info for this Device
510(K) Number	K181194
Device Name	Saliva, Artificial
Applicant	Triumph Pharmaceuticals, Inc. 12312 Olive Blvd., Ste. 250 St. Louis, MO 63141 US Other 510(k) Applications for this Company
Contact	Andrew Burch 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	05/04/2018
Decision Date	02/15/2019
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