FDA 510(k) Application Details - K202529

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K202529
Device Name	Device, Anti-Snoring
Applicant	ProSomnus Sleep Technologies, Inc. 5860 West Las Positas Blvd. 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	09/01/2020
Decision Date	11/20/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review