510(k) K894610

CUSTOM TRAYS, KITS by L H M Ent., Inc. — Product Code FSM

K894610 is an FDA 510(k) premarket notification submitted by L H M Ent., Inc. for the device "CUSTOM TRAYS, KITS". The FDA issued a decision of Substantially Equivalent (with conditions) on March 15, 1990. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. L H M Ent., Inc. has at least 5 other 510(k) clearances on record.