FDA 510(k) Application Details - K001381

Device Classification Name	Sterilant, Medical Devices   More FDA Info for this Device
510(K) Number	K001381
Device Name	Sterilant, Medical Devices
Applicant	ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	NEELU MEDHEKAR Other 510(k) Applications for this Contact
Regulation Number	880.6885   More FDA Info for this Regulation Number
Classification Product Code	MED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2000
Decision Date	05/17/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review