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Midwest Rf, LLC
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SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 is an FDA 510(k)-cleared medical device (K051618) manufactured by Midwest Rf, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 1, 2005. Regulation: 8.