510(k) K203753

Straumann Surgical Cassettes by Straumann USA, LLC — Product Code KCT

K203753 is an FDA 510(k) premarket notification submitted by Straumann USA, LLC for the device "Straumann Surgical Cassettes". The FDA issued a decision of Substantially Equivalent on July 29, 2021. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Straumann USA, LLC has at least 10 other 510(k) clearances on record.