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Magnum7419

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Magnum7419

Re: beach_trades post# 23960

Wednesday, 10/02/2019 10:36:50 AM

Wednesday, October 02, 2019 10:36:50 AM

Post# of 71248
"A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval"

https://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfpmn/pmn.cfm
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