FDA 510(k) Application Details - K203560

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K203560
Device Name	Indicator, Biological Sterilization Process
Applicant	TSO3 Inc., Now a part of Stryker 2505, avenue Dalton QuΘbec G1P 3S5 CA Other 510(k) Applications for this Company
Contact	Karan Modi 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	12/07/2020
Decision Date	03/24/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review