510(k) K103504

GETINGE 400HC/500HC SERIES STEAM STERILIZER by Getinge Sourcing, LLC — Product Code FLE

K103504 is an FDA 510(k) premarket notification submitted by Getinge Sourcing, LLC for the device "GETINGE 400HC/500HC SERIES STEAM STERILIZER". The FDA issued a decision of Substantially Equivalent on March 16, 2011. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Getinge Sourcing, LLC has at least 6 other 510(k) clearances on record.