FDA 510(k) Application Details - K191896

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K191896
Device Name	Sterilizer, Steam
Applicant	Belimed AG Grienbachstrasse 11 Zug 6300 CH Other 510(k) Applications for this Company
Contact	Marc Luthi 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	07/15/2019
Decision Date	10/31/2019
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