
Integra Lifesciences Corp.
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HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N is an FDA 510(k)-cleared medical device (K030289) manufactured by Integra Lifesciences Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 25, 2003. Regulation: 8.