FDA 510(k) Application Details - K221474

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K221474
Device Name	Sterilizer, Steam
Applicant	PRIMUS Sterilizer Company, LLC 7936 Forest City Road, Suite 100 Orlando, FL 32810 US Other 510(k) Applications for this Company
Contact	Patrick Hansen 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	05/20/2022
Decision Date	02/10/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review