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I emailed the FDA about this device, and the reply I received stated:   "This is in response to your email below to the U.S. Food and Drug Administration (FDA) requesting information on a medical device.In searching our database of FDA cleared devices, I was unable to find one listed with the name "Avacen." I noticed on the web site you provided it states that their product has not been evaluated by the FDA, therefore it currently does not have FDA marketing clearance and I have no information I can offer on it. "   Teri
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