510(k) K860528

THE KEYMED FIBERSCOPE STERILIZATION CASE by Keymed, Inc. — Product Code KCT

K860528 is an FDA 510(k) premarket notification submitted by Keymed, Inc. for the device "THE KEYMED FIBERSCOPE STERILIZATION CASE". The FDA issued a decision of Substantially Equivalent on July 15, 1986. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Keymed, Inc. has at least 10 other 510(k) clearances on record.