510(k) K182084

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) by Sweden & Martina S.P.A. — Product Code KCT

K182084 is an FDA 510(k) premarket notification submitted by Sweden & Martina S.P.A. for the device "Sweden & Martina Surgical Tray (Model ZSHORTY-INT)". The FDA issued a decision of Substantially Equivalent on Nov 4, 2020. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Sweden & Martina S.P.A. has 7 other 510(k) clearances on record.