
Pinsco Inc. Dba B & L Engineering
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X12 STERILE REFLECTIVE MARKER SPHERE is an FDA 510(k)-cleared medical device (K111443) manufactured by Pinsco Inc. Dba B & L Engineering. 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 28, 2011. Regulation: 8.