FDA 510(k) Application Details - K990246

Device Classification Name	Indicator, Physical/Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K990246
Device Name	Indicator, Physical/Chemical Sterilization Process
Applicant	STERITEC PRODUCTS MFG. CO., INC. 680 ATCHISON WAY SUITE 600 CASTLE ROCK, CO 80104 US Other 510(k) Applications for this Company
Contact	LON BRUSO 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	01/26/1999
Decision Date	06/10/1999
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