FDA 510(k) Application Details - K152660

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K152660
Device Name	Device, Anti-Snoring
Applicant	Somnics Inc. 5F , No.22, Sec. 2, Sheng Yi Road., Hsinchu Science Park Zhubei City Hsinchu County 30261 TW Other 510(k) Applications for this Company
Contact	TSUNG-MIN HSIEH 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	09/17/2015
Decision Date	11/09/2016
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