FDA 510(k) Application Details - K162306

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K162306
Device Name	Device, Anti-Snoring
Applicant	SomnoMed Inc. 7460 Warren Pkwy Ste 190 Frisco, TX 75034 US Other 510(k) Applications for this Company
Contact	Kien Nguyen 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	08/17/2016
Decision Date	09/20/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review