SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY is an FDA 510(k)-cleared medical device (K955174) manufactured by Sodem Diffusion SA. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 21, 1996. Regulation: 8.