510(k) K801010

KIRSCHNER WIRE by American Safety Equipment Corp. — Product Code HSB

K801010 is an FDA 510(k) premarket notification submitted by American Safety Equipment Corp. for the device "KIRSCHNER WIRE". The FDA issued a decision of Substantially Equivalent on May 20, 1980. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. American Safety Equipment Corp. has at least 6 other 510(k) clearances on record.