FDA 510(k) Application Details - K162662

Device Classification Name	Cord, Retraction   More FDA Info for this Device
510(K) Number	K162662
Device Name	Cord, Retraction
Applicant	PAC-DENT INTERNATIONAL, INC. 670 ENDEAVOR CIRCLE BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	JIAQING WU Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MVL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2016
Decision Date	10/20/2017
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