510(k) K080531

CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY by Conmed Linvatec — Product Code KCT

K080531 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY". The FDA issued a decision of Substantially Equivalent on September 5, 2008. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Conmed Linvatec has at least 10 other 510(k) clearances on record.