510(k) K080558

STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS by Case Medical, Inc. — Product Code FRG

K080558 is an FDA 510(k) premarket notification submitted by Case Medical, Inc. for the device "STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS". The FDA issued a decision of Substantially Equivalent on December 5, 2008. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Case Medical, Inc. has at least 10 other 510(k) clearances on record.