FDA 510(k) Application Details - K190359

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K190359
Device Name	Scaler, Ultrasonic
Applicant	Sonendo, Inc. 26061 Merit Circle Laguna Hills, CA 92653 US Other 510(k) Applications for this Company
Contact	Eric Simon Other 510(k) Applications for this Contact
Regulation Number	872.4850   More FDA Info for this Regulation Number
Classification Product Code	ELC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2019
Decision Date	03/16/2019
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