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Riverpoint Medical
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BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS is an FDA 510(k)-cleared medical device (K103449) manufactured by Riverpoint Medical. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 2011. Regulation: 8.