510(k) K093333

PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 by Primus Sterilizer Company, LLC — Product Code FLE

K093333 is an FDA 510(k) premarket notification submitted by Primus Sterilizer Company, LLC for the device "PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8". The FDA issued a decision of Substantially Equivalent on April 2, 2010. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Primus Sterilizer Company, LLC has at least 3 other 510(k) clearances on record.