FDA 510(k) Application Details - K163580

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K163580
Device Name	Device, Anti-Snoring
Applicant	AMERICAN SLEEP DENTISTRY 1957 WEST ROYAL HUNTE DRIVE STE 250 CEDAR CITY, UT 84720-1903 US Other 510(k) Applications for this Company
Contact	RYAN GREGERSON 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	12/20/2016
Decision Date	06/08/2017
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