FDA 510(k) Application Details - K200748

Device Classification Name	More FDA Info for this Device
510(K) Number	K200748
Device Name	Visby Medical Sexual Health
Applicant	Visby Medical 3010 N. First Street San Jose, CA 95134 US Other 510(k) Applications for this Company
Contact	Carolyn Glickman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2020
Decision Date	08/26/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review