GERTIE MARX NEEDLE

GERTIE MARX NEEDLE is an FDA 510(k)-cleared medical device (K931644) manufactured by Intl. Medical-Dental Products USA, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 21, 1993. Regulation: 8.