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    UltraShape on Fasttrack to Receive FDA Clearance

    UltraShape on Fasttrack to Receive FDA Clearance

    June 09, 2010

    UltraShape Ltd. recently announced that the US Food and Drug Administration advised the company that it may submit a request for clearance of its Contour I system under the 510(k) regulation rather than as a Pre-Market Approval (PMA) as was previously advised which should shorten the FDA clearance process

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