GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L

GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L is an FDA 510(k)-cleared medical device (K903402) manufactured by Medi-Source, 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 August 21, 1990. Regulation: 8.