FDA 510(k) Application Details - K160477

Device Classification Name	Mouthguard, Migraine/Tension Headache   More FDA Info for this Device
510(K) Number	K160477
Device Name	Mouthguard, Migraine/Tension Headache
Applicant	LUCO HYBRID OSA APPLIANCE INC. 1419 BUTTERNUT CREEK ROAD KINGSTON K7L 4V3 CA Other 510(k) Applications for this Company
Contact	Ken Luco Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OCO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2016
Decision Date	07/29/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review