FDA 510(k) Application Details - K130797

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K130797
Device Name	Device, Anti-Snoring
Applicant	LUCO HYBRID OSA APPLIANCE INC. 1419 BUTTERNUT CREEK ROAD KINGSTON, ONTARIO K7L 5H6 CA Other 510(k) Applications for this Company
Contact	KEN LUCO Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	LRK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2013
Decision Date	12/18/2013
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