GENERAL PURPOSE ATL NEEDLE GUIDE KIT

GENERAL PURPOSE ATL NEEDLE GUIDE KIT is an FDA 510(k)-cleared medical device (K973958) manufactured by Protek Medical Products, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 1998. Regulation: 8.