FDA 510(k) Application Details - K142034

Device Classification Name	Sterilizer, Ethylene-Oxide Gas   More FDA Info for this Device
510(K) Number	K142034
Device Name	Sterilizer, Ethylene-Oxide Gas
Applicant	3M COMPANY 3M CENTER, BUILDING 275-SW-06 ST. PAUL, MN 55144 US Other 510(k) Applications for this Company
Contact	MATT MORTENSEN Other 510(k) Applications for this Contact
Regulation Number	880.6860   More FDA Info for this Regulation Number
Classification Product Code	FLF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2014
Decision Date	01/08/2015
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