FDA 510(k) Application Details - K160903

Device Classification Name	Sterilizer, Chemical   More FDA Info for this Device
510(K) Number	K160903
Device Name	Sterilizer, Chemical
Applicant	ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DRIVE Irvine, CA 92617 US Other 510(k) Applications for this Company
Contact	JAMIE BYUN Other 510(k) Applications for this Contact
Regulation Number	880.6860   More FDA Info for this Regulation Number
Classification Product Code	MLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2016
Decision Date	09/26/2016
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