FDA 510(k) Application Details - K192978

Device Classification Name	Sterilizer, Ethylene-Oxide Gas   More FDA Info for this Device
510(K) Number	K192978
Device Name	Sterilizer, Ethylene-Oxide Gas
Applicant	Andersen Sterilizers, Inc. 3154 Caroline Drive Haw River, NC 27258 US Other 510(k) Applications for this Company
Contact	William K. Andersen 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	10/24/2019
Decision Date	11/12/2020
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