FDA 510(k) Application Details - K221641

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K221641
Device Name	Indicator, Biological Sterilization Process
Applicant	Terragene SA Ruta Nacional No. 9, Km 280, Parque Industrial Micropi Alvear 2130 AR Other 510(k) Applications for this Company
Contact	Hernando Carrizo Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	FRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2022
Decision Date	02/28/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review