510(k) K101653

MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES by Miltex, Inc. — Product Code KCT

K101653 is an FDA 510(k) premarket notification submitted by Miltex, Inc. for the device "MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES". The FDA issued a decision of Substantially Equivalent on August 2, 2010. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Miltex, Inc. has at least 10 other 510(k) clearances on record.