FDA 510(k) Application Details - K143520

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K143520
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	CROSSTEX 6789 WEST HENRIETTA ROAD RUSH, NY 14543 US Other 510(k) Applications for this Company
Contact	Michael G Nolan Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	JOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2014
Decision Date	06/09/2015
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