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Small Uptick In 510(k) Clearances In Fiscal 2014

This article was originally published in The Gray Sheet

Executive Summary

FDA cleared 3,103 510(k)s in the fiscal year that ended Sept. 30, averaging about 259 per month, based on a review a FDA’s monthly 510(k) listings. That is up from 2,995 clearances – a 250 per-month average – in FY 2013.

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