FDA 510(k) Application Details - K023290

Device Classification Name	Sterilizer, Ethylene-Oxide Gas   More FDA Info for this Device
510(K) Number	K023290
Device Name	Sterilizer, Ethylene-Oxide Gas
Applicant	ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	NATALIE BENNINGTON 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	10/02/2002
Decision Date	04/03/2003
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