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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service SOPRO-Acteon Group 0U Rick Rosati Quality Manager Satelec Acteon Group 124 Gaither Drive Suite 140 MT LAUREL NJ 08054 September 5 2014 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring MD 20993-0002 Re K140013...
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Sopro-Acteon Group is a French company specializing in the design and manufacturing of dental and medical equipment.
Any individual or entity that owns shares or has a financial interest in Sopro-Acteon Group may be required to file.
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The purpose of the Sopro-Acteon Group report is to disclose ownership and financial information to regulatory authorities.
Information such as ownership details, financial interests, and any other relevant information must be reported on the Sopro-Acteon Group report.
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