FDA 510(k) Application Details - K231138

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K231138
Device Name	Device, Anti-Snoring
Applicant	Oscimed SA AllΘe du Quartz 3 2300 La Chaux-de-Fonds Suisse 2300 CH Other 510(k) Applications for this Company
Contact	Jacques Magnin 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	04/21/2023
Decision Date	01/16/2024
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