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Replies to post #6074 on Lexington Biosciences Inc. (LXGTF)

Replies to #6074 on Lexington Biosciences Inc. (LXGTF)

Door2Door

12/22/17 7:15 PM

#6075 RE: Door2Door #6074

Average time to market for a cardiovascular device in the 510k FDA program is 6 months.

MauiMoMo

12/22/17 7:21 PM

#6077 RE: Door2Door #6074

Curious how the 510K program could be for devices with a "proven" life saving application. How can it be "proven" when the clinical tests haven't been done yet?