JELENKO NO.1 (CODE NAME RD-0601)

JELENKO NO.1 (CODE NAME RD-0601) is an FDA 510(k)-cleared medical device (K970068) manufactured by J.F. Jelenko & Co., Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 1997. Regulation: 8.