FDA 510(k) Application Details - K162192

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K162192
Device Name	Device, Anti-Snoring
Applicant	BlueSom 24 rue Leon Gaumont Orvault 44700 FR Other 510(k) Applications for this Company
Contact	Erwan Floch 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	08/04/2016
Decision Date	12/15/2016
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