510(k) K811002

ENDER PINS by Richard'S Medical Equip., Inc. — Product Code HSB

K811002 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "ENDER PINS". The FDA issued a decision of Substantially Equivalent on April 29, 1981. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.