FDA 510(k) Application Details - K140777

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K140777
Device Name	Device, Anti-Snoring
Applicant	SLEEPING WELL, LLC 342 E. MAIN STREET, STE 207 LEOLA, PA 17540 US Other 510(k) Applications for this Company
Contact	WILLIAM MCLAIN 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	03/28/2014
Decision Date	07/25/2014
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