FDA 510(k) Application Details - K233497

Device Classification Name	More FDA Info for this Device
510(K) Number	K233497
Device Name	Rest Assure System
Applicant	Somnomed, Inc. 6513 Windcrest Drive, Suite 100 Plano, TX 75024 US Other 510(k) Applications for this Company
Contact	Ty Cowart Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2023
Decision Date	10/03/2024
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