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A 510(k) may be used for both: New devices that a manufacturer intends to market for the first time When a manufacturer intends to reintroduce a device that has been significantly changed or modified to an extent that might affect its safety or effectiveness

Not for human consumption, therapeutic use, or diagnostic application

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Must be used under medical supervision

Food and Drug Administration approved its daily oral orforglipron pill, which will be marketed under the name Foundayo, to treat obesity

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