FDA 510(k) Application Details - K190236

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K190236
Device Name	Device, Anti-Snoring
Applicant	Oventus Manufacturing PTY LTD 1 Swann Road Indooroopilly 4068 AU Other 510(k) Applications for this Company
Contact	Robyn Woidtke 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	02/06/2019
Decision Date	08/29/2019
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