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Cytomedix (AMEX : GTF )
Market Cap : 18,8 Mio$ Price : 0,50 $
Shares Out : 37,3 M
On August 7, 2009, Cytomedix, Inc. (NYSE AMEX:GTF) announced that it has submitted to, the United Sates of America’s toughest regulator, the Food and Drug Administration (FDA) a 510(K) for its AutoloGel™ Platelet Separation System. The 510(K) submission was made to obtain pre market approval from the FDA. We anticipate they will get a response from the FDA after 6 months, i.e. on or around February 7, 2010. However, the FDA may not give its decision on this date and there is no way to find out when it will, since the FDA is not bound by law to notify about decision dates for any submission, such as 510(K), related to medical devices.