510(k) K974638

STERITITE SEALED CONTAINERS MODEL SCO4Q by Case Medical, Inc. — Product Code FRG

K974638 is an FDA 510(k) premarket notification submitted by Case Medical, Inc. for the device "STERITITE SEALED CONTAINERS MODEL SCO4Q". The FDA issued a decision of Substantially Equivalent on December 18, 1997. 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.