WASHINGTON, Dec. 10 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Envoy Medical Inc. from the Center for Devices and Radiological Health:

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Recipient: Brent T. Lucas, CEO & Director, Envoy Medical Inc., 4875 White Bear Parkway, Saint Paul, MN 55110-3325, United States, blucas@envoymedical.com

Issuing Office: Center for Devices and Radiological Health, United States