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Eli's Gone

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Re: A deleted message

Friday, 04/07/2017 5:16:13 PM

Friday, April 07, 2017 5:16:13 PM

Post# of 52074
We've been told for years we'd fall under 880.6890

Class I Medical Device exempt from premarket 510(k) filing

Not sure if Esposito is fighting for this classification or out of FDA purview entirely as he recently stated

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=880.6890

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