FDA 510(k) Application Details - K163029

Device Classification Name	Saliva, Artificial   More FDA Info for this Device
510(K) Number	K163029
Device Name	Saliva, Artificial
Applicant	BIOPHARM CONSULT, L.L.C. 5609 HARD ROCK PLACE HENRICO, VA 23230 US Other 510(k) Applications for this Company
Contact	DAVID S. JOHNSON 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	10/31/2016
Decision Date	06/19/2017
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