FDA 510(k) Application Details - K162816

Device Classification Name	Device, Jaw Repositioning   More FDA Info for this Device
510(K) Number	K162816
Device Name	Device, Jaw Repositioning
Applicant	SELANE PRODUCTS, INC. 9129 LURLINE AVENUE CHATSWORTH, CA 91311 US Other 510(k) Applications for this Company
Contact	JOHN CHRISTIAN Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	LQZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/06/2016
Decision Date	07/27/2017
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