PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT

PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT is an FDA 510(k)-cleared medical device (K951258) manufactured by Pudenz-Schulte Medical Research 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 September 17, 1995. Regulation: 8.