510(k) K954185

RE-BAG MULTI-USE POUCH, LARGE & SMALL by Miltex, Inc. — Product Code KCT

K954185 is an FDA 510(k) premarket notification submitted by Miltex, Inc. for the device "RE-BAG MULTI-USE POUCH, LARGE & SMALL". The FDA issued a decision of Substantially Equivalent (kit) on December 4, 1995. 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.