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Supreme Court Questions Whether 510(k) "Intended Use" Must Be Bona Fide

This article was originally published in The Gray Sheet

Executive Summary

The "intended use" statement in a 510(k) is "not a factual representation" of how a device will be used on the market, Kenneth Geller, attorney for the Buckman Co., contended before the U.S. Supreme Court Dec. 4.

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