FDA 510(k) Application Details - K131138

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K131138
Device Name	Device, Anti-Snoring
Applicant	RESPIRE MEDICAL 22817 VENTURA BLVD #161 WOODLAND HILLS, CA 91364 US Other 510(k) Applications for this Company
Contact	DANIELA LEVY 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	04/23/2013
Decision Date	09/09/2013
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