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Given Wireless Endoscopy System 510(k) Submission Planned By Dec. 1

This article was originally published in The Gray Sheet

Executive Summary

Given Imaging expects to file a 510(k) with FDA for the Given wireless endoscopy diagnostic imaging system by Dec. 1. The submission will include results from a 20-patient, single-center study, expected to commence by Oct. 1, the firm says.

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