FDA 510(k) Application Details - K181434

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K181434
Device Name	Indicator, Biological Sterilization Process
Applicant	Crosstex/SPSmedical, A Division of Cantel Medical 6789 West Henrietta Road Rush, NY 14543 US Other 510(k) Applications for this Company
Contact	Megan Skaar 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	06/01/2018
Decision Date	11/14/2018
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