FDA 510(k) Application Details - K213991

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K213991
Device Name	Sterilizer, Steam
Applicant	Enbio Group AG Eichengasse 3 Oensingen CH-4702 CH Other 510(k) Applications for this Company
Contact	Lukasz Rogowski 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	12/21/2021
Decision Date	02/22/2022
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