FDA 510(k) Application Details - DEN240045

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240045
Device Name	Teal Wand
Applicant	Teal Health, Inc. 1012 Torney Ave San Francisco, CA 94129 US Other 510(k) Applications for this Company
Contact	Trena Depel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SEP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2024
Decision Date	05/09/2025
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review