510(k) K031259

MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER by Getinge USA, Inc. — Product Code FLE

K031259 is an FDA 510(k) premarket notification submitted by Getinge USA, Inc. for the device "MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER". The FDA issued a decision of Substantially Equivalent on May 12, 2003. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Getinge USA, Inc. has at least 3 other 510(k) clearances on record.