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This article was originally published in The Gray Sheet
The Division of General and Restorative Devices in FDA's Office of Device Evaluation reduces the backlog of overdue 510(k)s for restorative devices to less than 50 submissions, down from 168 in August. The division-wide total of 904 510(k)s pending at the end of September is about half the 1,880 pending in September 1993
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