510(k) K050570

MILTEX RIGID STERILIZATION CONTAINER SYSTEM by Miltex, Inc. — Product Code KCT

K050570 is an FDA 510(k) premarket notification submitted by Miltex, Inc. for the device "MILTEX RIGID STERILIZATION CONTAINER SYSTEM". The FDA issued a decision of Substantially Equivalent on July 25, 2005. 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.