FDA 510(k) Application Details - K221547

Device Classification Name	More FDA Info for this Device
510(K) Number	K221547
Device Name	InActiv Blue
Applicant	FertiPro NV Industriepark Noord 32 Beernem 8730 BE Other 510(k) Applications for this Company
Contact	Liesbeth Faes Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/2022
Decision Date	06/11/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review