510(k) K141616

STERILIZATION CASSETTE by Oticon Medical AB — Product Code KCT

K141616 is an FDA 510(k) premarket notification submitted by Oticon Medical AB for the device "STERILIZATION CASSETTE". The FDA issued a decision of Substantially Equivalent on September 23, 2014. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Oticon Medical AB has at least 10 other 510(k) clearances on record.