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FDA Makes ReGen Biologics, Inc. (RGBI) 510(k) Rescission Final



3/1/2011 2:17:46 PM

Mass Device -- ReGen Biologics Inc. (OTC:RGBO) is weighing options for the Menaflex knee implant the FDA forced off the market last week. The agency rescinded its 2008 510(k) clearance for the Hackensack, N.J.-based company's embattled bio-absorbable knee implant last October. Last month ReGen rebuffed an offer from the FDA for a final hearing on the decision.

Read at MassDevice


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