SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30

SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 is an FDA 510(k)-cleared medical device (K051045) manufactured by Spectrx, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 1, 2005. Regulation: 8.