FDA 510(k) Application Details - K133267

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K133267
Device Name	Indicator, Biological Sterilization Process
Applicant	DANA PRODUCTS, INC. 7 COREY DR. SOUTH BARRINGTON, IL 60010 US Other 510(k) Applications for this Company
Contact	HARRY BALA 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	10/24/2013
Decision Date	02/11/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review