
Precision Dynamics Corp.
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SECURLINE FRANSEENE NEEDLE is an FDA 510(k)-cleared medical device (K873369) manufactured by Precision Dynamics Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 19, 1987. Regulation: 8.