
Sophysa SA
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SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 is an FDA 510(k)-cleared medical device (K013488) manufactured by Sophysa 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 March 26, 2002. Regulation: 8.