FDA 510(k) Application Details - K053212

Device Classification Name	Indicator, Biological, Liquid Chemical Sterilization Process   More FDA Info for this Device
510(K) Number	K053212
Device Name	Indicator, Biological, Liquid Chemical Sterilization Process
Applicant	RAVEN BIOLOGICAL LABORATORIES, INC. 8607 PARK DR. OMAHA, NE 68127 US Other 510(k) Applications for this Company
Contact	WENDY ROYALTY-HANN Other 510(k) Applications for this Contact
Regulation Number	880.2800   More FDA Info for this Regulation Number
Classification Product Code	MRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2005
Decision Date	02/15/2006
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