FDA 510(k) Application Details - DEN240020

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240020
Device Name	Visby Medical Women's Sexual Health Test
Applicant	Visby Medical, Inc. 3010 North First Street San Jose, CA 95134 US Other 510(k) Applications for this Company
Contact	Jennifer Albrecht Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2024
Decision Date	03/28/2025
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