510(k) K080250

LEKSELL SURGIPLAN, MODEL 1006947 by Elekta Instrument AB — Product Code HAW

K080250 is an FDA 510(k) premarket notification submitted by Elekta Instrument AB for the device "LEKSELL SURGIPLAN, MODEL 1006947". The FDA issued a decision of Substantially Equivalent on May 13, 2008. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Elekta Instrument AB has at least 10 other 510(k) clearances on record.