FDA 510(k) Application Details - K083650

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K083650
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	STERITEC PRODUCTS, INC. 599 TOPEKA WAY, SUITE 400 CASTLE ROCK, CO 80109 US Other 510(k) Applications for this Company
Contact	LINDA NELSON 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	12/09/2008
Decision Date	03/05/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review