FDA 510(k) Application Details - K133549

Device Classification Name	Indicator, Biological Sterilization Process   More FDA Info for this Device
510(K) Number	K133549
Device Name	Indicator, Biological Sterilization Process
Applicant	STERITEC PRODUCTS MFG., CO., INC. 74 INVERNESS DRIVE EAST ENGLEWOOD, CO 80112 US Other 510(k) Applications for this Company
Contact	JONATHAN RUTIGLIANO 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	11/19/2013
Decision Date	08/27/2014
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