FDA 510(k) Application Details - K243801

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K243801
Device Name	Sterilizer, Steam
Applicant	Fort Defiance Industries LLC 2411 Maremont Parkway Loudon, TN 37774 US Other 510(k) Applications for this Company
Contact	Chris Coleman Other 510(k) Applications for this Contact
Regulation Number	880.6880   More FDA Info for this Regulation Number
Classification Product Code	FLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2024
Decision Date	03/07/2025
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