FDA 510(k) Application Details - K234015

Device Classification Name	Saliva, Artificial   More FDA Info for this Device
510(K) Number	K234015
Device Name	Saliva, Artificial
Applicant	EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way Hemel Hempstead HP2 4TZ GB Other 510(k) Applications for this Company
Contact	Sandy Suh 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	12/19/2023
Decision Date	03/11/2024
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