FDA 510(k) Application Details - K183443

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K183443
Device Name	Device, Anti-Snoring
Applicant	SomnoMed Inc. 6513 Windcrest Drive Plano, TX 75024 US Other 510(k) Applications for this Company
Contact	Dorene Markwiese 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	12/12/2018
Decision Date	05/08/2019
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	N
Expedited Review