FDA 510(k) Application Details - K242538

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K242538
Device Name	Indicator, Biological Sterilization Process
Applicant	3M Company 3M Center 2510 Conway Ave., Building 275-5W-06 St. Paul, MN 55144 US Other 510(k) Applications for this Company
Contact	Michelle Larsen 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	08/26/2024
Decision Date	11/25/2024
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