FDA 510(k) Application Details - DEN200006

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200006
Device Name	ClearUP Sinus Relief
Applicant	Tivic Health Systems Inc. 750 Menlo Ave Suite 200 Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Michael Nketiah Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2020
Decision Date	03/05/2021
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review