FDA 510(k) Application Details - K221889

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K221889
Device Name	Device, Anti-Snoring
Applicant	ProSomnus Sleep Technologies 5860 W Las Positas Blvd. Suite 25 Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Divya Mavalli 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	06/29/2022
Decision Date	10/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review