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ANTI-BAGHOLDER

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ANTI-BAGHOLDER

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Re: ProfitChaser post# 307

Thursday, 03/07/2024 8:46:27 AM

Thursday, March 07, 2024 8:46:27 AM

Post# of 362
510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

If they can keep dilution down there may be some big upside here
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