FDA 510(k) Application Details - K210481

Device Classification Name	Indicator,Chemical,Enzymatic,Sterilization Process   More FDA Info for this Device
510(K) Number	K210481
Device Name	Indicator,Chemical,Enzymatic,Sterilization Process
Applicant	True Indicating LLC 946 Kane St Toledo, OH 43612 US Other 510(k) Applications for this Company
Contact	Thomas Riha Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	MTC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2021
Decision Date	12/14/2021
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