FDA 510(k) Application Details - K014013

Device Classification Name	Sterilizer, Ethylene-Oxide Gas   More FDA Info for this Device
510(K) Number	K014013
Device Name	Sterilizer, Ethylene-Oxide Gas
Applicant	H & W TECHNOLOGY, LLC P.O. BOX 20281 ROCHESTER, NY 14602-0281 US Other 510(k) Applications for this Company
Contact	CHARLES O HANCOCK 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	12/05/2001
Decision Date	06/25/2003
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