FDA 510(k) Application Details - K170304

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K170304
Device Name	Sterilizer, Steam
Applicant	Astell Scientific Limited 19-21 Powerscroft Rd Sidcup DA14 5DT GB Other 510(k) Applications for this Company
Contact	Gary Doughty 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	01/31/2017
Decision Date	03/02/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review