FDA 510(k) Application Details - K200536

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K200536
Device Name	Indicator, Biological Sterilization Process
Applicant	3M Complany 3M Center, Building 275-5W-06 St. Paul, MN 55144 US Other 510(k) Applications for this Company
Contact	Mary Fretland 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	03/03/2020
Decision Date	06/01/2020
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