FDA 510(k) Application Details - K223858

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K223858
Device Name	Sterilizer, Steam
Applicant	W&H Sterilization S.r.l. Via Bolgara, 2 Brusaporto 24060 IT Other 510(k) Applications for this Company
Contact	Paola Zampino 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	12/23/2022
Decision Date	05/05/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review