
Vygon Us, LLC
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MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS is an FDA 510(k)-cleared medical device (K033704) manufactured by Vygon Us, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 26, 2004. Regulation: 8.