FDA 510(k) Application Details - K192937

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K192937
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	3M Company 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	JOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2019
Decision Date	11/16/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review