510(k) K180791

Straumann BLX Surgical Cassette by Institut Straumann AG — Product Code KCT

K180791 is an FDA 510(k) premarket notification submitted by Institut Straumann AG for the device "Straumann BLX Surgical Cassette". The FDA issued a decision of Substantially Equivalent on Jun 21, 2018. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Institut Straumann AG has 91 other 510(k) clearances on record.