510(k) K193603

Benesta Medical Sterilization Tray by Caldera Medical, Inc. — Product Code KCT

K193603 is an FDA 510(k) premarket notification submitted by Caldera Medical, Inc. for the device "Benesta Medical Sterilization Tray". The FDA issued a decision of Substantially Equivalent on July 20, 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. Caldera Medical, Inc. has at least 10 other 510(k) clearances on record.