510(k) K954717

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY by Sodem Diffusion SA — Product Code HBB

K954717 is an FDA 510(k) premarket notification submitted by Sodem Diffusion SA for the device "SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY". The FDA issued a decision of Substantially Equivalent on January 22, 1997. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Sodem Diffusion SA has at least 2 other 510(k) clearances on record.