FDA 510(k) Application Details - K172452

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K172452
Device Name	Mouthguard, Over-The-Counter
Applicant	Sleep Specialties, LLC 2565 South Las Vegas Blvd.,Suite #184 Las Vegas, NV 89109 US Other 510(k) Applications for this Company
Contact	James S. Fallon Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2017
Decision Date	01/11/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review