510(k) K061033

MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) by Miltex, Inc. — Product Code KCT

K061033 is an FDA 510(k) premarket notification submitted by Miltex, Inc. for the device "MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)". The FDA issued a decision of Substantially Equivalent on December 12, 2006. 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.