FDA 510(k) Application Details - K202651

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K202651
Device Name	Device, Anti-Snoring
Applicant	Orthoapnea S.L. C / Flauta Magica 22 Malaga 29006 ES Other 510(k) Applications for this Company
Contact	Jose Repolles Llecha 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	09/14/2020
Decision Date	02/12/2021
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