FDA 510(k) Application Details - K170039

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K170039
Device Name	Indicator, Biological Sterilization Process
Applicant	Advanced Sterilization Products (ASP) 33 Technology Drive Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Sun Choi 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	01/05/2017
Decision Date	06/20/2017
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