FDA 510(k) Application Details - K250390

Device Classification Name	Saliva, Artificial   More FDA Info for this Device
510(K) Number	K250390
Device Name	Saliva, Artificial
Applicant	Rowpar Pharmaceuticals Inc. 440 US Highway 22 Suite 210 Bridgewater, NJ 08807 US Other 510(k) Applications for this Company
Contact	Michael Tune 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	02/11/2025
Decision Date	05/19/2025
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