FDA 510(k) Application Details - K181456

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K181456
Device Name	Sterilizer, Steam
Applicant	Tuttnauer Ltd. Har Tuv B Industrial Park Beit Shemesh IL Other 510(k) Applications for this Company
Contact	Aline Peled 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	06/04/2018
Decision Date	07/08/2019
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