FDA 510(k) Application Details - K082392

Device Classification Name	Accessories, Cleaning, For Endoscope   More FDA Info for this Device
510(K) Number	K082392
Device Name	Accessories, Cleaning, For Endoscope
Applicant	ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	JOSEPH ASCENZI, PH.D. Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2008
Decision Date	11/13/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review