
Sodem Diffusion SA
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SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY is an FDA 510(k)-cleared medical device (K954717) manufactured by Sodem Diffusion SA. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 1997. Regulation: 8.

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