510(k) K955174

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY by Sodem Diffusion SA — Product Code GET

K955174 is an FDA 510(k) premarket notification submitted by Sodem Diffusion SA for the device "SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY". The FDA issued a decision of Substantially Equivalent on January 22, 1996. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Sodem Diffusion SA has at least 2 other 510(k) clearances on record.