FDA 510(k) Application Details - K160720

Device Classification Name	Bracket, Plastic, Orthodontic   More FDA Info for this Device
510(K) Number	K160720
Device Name	Bracket, Plastic, Orthodontic
Applicant	ORTHO ORGANIZERS, INC. 1822 ASTON AVENUE CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	COLLEEN BOSWELL Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	DYW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2016
Decision Date	11/28/2016
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