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This article was originally published in The Gray Sheet
Shipments of the noninvasive glucose monitors to European distributor Eurosurgical, Ltd. commence on July 9 following receipt of a CE mark July 2. U.S. debut of the system hinges on FDA clearance of a 510(k) pending at FDA. A revised version of an original 1994 application was filed with the agency in 1996 ("The Gray Sheet" Oct. 14, 1996, In Brief)
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