FDA 510(k) Application Details - K141312

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K141312
Device Name	Indicator, Biological Sterilization Process
Applicant	STERILUCENT, INC 1400 MARSHALL STREET NE MINNEAPOLIS, MN 55413 US Other 510(k) Applications for this Company
Contact	PETER KALKBRENNER 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	05/20/2014
Decision Date	10/31/2014
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