FDA 510(k) Application Details - K991675

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K991675
Device Name	Indicator, Biological Sterilization Process
Applicant	ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	KEVIN CORRIGAN Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	FRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/1999
Decision Date	06/15/1999
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