FDA 510(k) Application Details - K200092

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K200092
Device Name	Indicator, Biological Sterilization Process
Applicant	3M 2510 Conway Ave, Bldg 275-5W-06 St. Paul, MN 55144-1000 US Other 510(k) Applications for this Company
Contact	Andrew Wingen 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	01/16/2020
Decision Date	04/15/2020
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