FDA 510(k) Application Details - K152201

Device Classification Name	Saliva, Artificial   More FDA Info for this Device
510(K) Number	K152201
Device Name	Saliva, Artificial
Applicant	MedActive Oral Pharmaceuticals, LLC. 1900 Gunn Highway Odessa, FL 33556 US Other 510(k) Applications for this Company
Contact	Brian Walker 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	08/06/2015
Decision Date	12/30/2015
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