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Somanetics

This article was originally published in The Gray Sheet

Executive Summary

Will submit a new 510(k) for its INVOS 3100 cerebral oximeter; the firm cites "timing and costs" as reasons for reversing plans to appeal FDA's Nov. 12 rescission of the device's 510(k) ("The Gray Sheet" Dec. 6, I&W-1). The company says the new filing is "the most efficient and timely way to satisfy the FDA and resume domestic sales of its product." Somanetics says the new 510(k) will address agency concerns with data integrity in the original 510(k). The company also reports that it is taking measures to reduce its current operating costs "by approximately 40%" and is extending the redemption date of its Class B warrants to May 4, 1995
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