FDA 510(k) Application Details - K250172

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K250172
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	SteriTec Products, Inc. (a Getinge Company) 74 Inverness Drive East Engelwood, CO 80112 US Other 510(k) Applications for this Company
Contact	Chris Muha 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	01/21/2025
Decision Date	02/20/2025
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