PROGEL(TM), MODELS 8630 AND 8635

PROGEL(TM), MODELS 8630 AND 8635 is an FDA 510(k)-cleared medical device (K882887) manufactured by Medical Devices, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 28, 1988. Regulation: 8.