OMI OCCIPITAL CERVICAL LOOP, MODEL A1089

OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 is an FDA 510(k)-cleared medical device (K983282) manufactured by Ohio Medical Instrument Co., Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 1998. Regulation: 8.