FDA 510(k) Application Details - K182017

Device Classification Name	More FDA Info for this Device
510(K) Number	K182017
Device Name	Compex HD
Applicant	AdDent, Inc. 43 Miry Brook Road Danbury, CT 06810 US Other 510(k) Applications for this Company
Contact	Joshua Friedman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2018
Decision Date	04/29/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review