FDA 510(k) Application Details - K082817

Device Classification Name	Sterilizer, Steam   More FDA Info for this Device
510(K) Number	K082817
Device Name	Sterilizer, Steam
Applicant	PRIMUS STERILIZER COMPANY, LLC. 5520 10TH ST. GREAT BEND, KS 67530 US Other 510(k) Applications for this Company
Contact	LYLE LOHRMEYER Other 510(k) Applications for this Contact
Regulation Number	880.6880   More FDA Info for this Regulation Number
Classification Product Code	FLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2008
Decision Date	05/21/2009
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	Y
Expedited Review