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Hi my name is ***** ***** I am happy to assist you. Are you asking if you need FDA approval as an importer or what exactly is your request? Do you have the products made in a different country then you purchase that product sndcsake under your company?
not for company...need a FDA approval about the product?
we want to import similar one below...
Hi yes you will need to do a Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. You can see how to do that by clicking this link here if you need my help with this please let me know