FDA 510(k) Application Details - K152292

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K152292
Device Name	Device, Anti-Snoring
Applicant	Respire Medical Holding 18 Bridge Street Suite 4J Brooklyn, NY 11201 US Other 510(k) Applications for this Company
Contact	David Walton 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	08/13/2015
Decision Date	12/07/2015
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