510(k) K912052

HEART CATH TRAY by Medical Device Inspection Co., Inc. — Product Code FSM

K912052 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "HEART CATH TRAY". The FDA issued a decision of Substantially Equivalent on August 20, 1991. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.