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Cooper Surgical
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TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS is an FDA 510(k)-cleared medical device (K091325) manufactured by Cooper Surgical. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2009. Regulation: 8.