MW Medical, Inc. Announces F.D.A. Approval to Market Microwave Delivery System (MDS), Model MMC-300
28.10.1999, 13:14
PARADISE VALLEY, Ariz. (PROTEXT) - MW Medical, Inc., a NevadaCompany, (the "Company") announces that on October 25, 1999, vialetter, the United States Department of Health and HumanServices, Food and Drug Administration, granted the Companyapproval to begin marketing the Company's Microwave DeliverySystem Model MMC-300 device. The Food and Drug Administration(F.D.A.) completed its review of the Company's Section 510(k)notification of intent to market this device and determined thedevice to be substantially equivalent for the purpose of theremoval of unwanted, non-facial body hair to devices marketed ininterstate commerce prior to May 28, 1976 (enactment date of theMedical Device Amendments) or to devices that have beenreclassified in accordance with the provisions of the FederalFood, Drug, and Cosmetic Act (Act). The device has beenclassified into Class II (Special Controls). The Company may,therefore, market this device subject to the general controlsprovisions of the Act, including requirements for annualregistration, listing of devices, good manufacturing practice,labeling, and prohibitions against misbranding and adulteration,and the additional controls mandated by the Class IIclassification. For More Information, Contact: Jan Wallace, Chairman of theBoard, 480-483-8700. ots Original Text Service: MW Medical, Inc.Internet: http://www.newsaktuell.de Contact: Jan Wallace,Chairman of the Board of MW Medical, Inc., 480-483-8700 Website: http://www.mwmd.com
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