World Health Organization / Food and Drug Administration / Center for Devices and Radiological Health / Radiological Health / Immunology and Hematology Devices Office / FDA / Division of Immunology / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Posimarket Surveillance / Radiological Health Center for Devices and Radiological Health Enclosure Food and Drug Administration Expiration Date / CDRH's office of Surveillance / Center for Devices / /
Person
Maria M. Chan / Adminisflhin / ROBERT MANN / / /
Position
CPA / Director / calibrator / SENIOR REGULATORY AFFAIRS MANAGER / Ph. Director / /
DEC[removed]k) Summary of Safety and Effectiveness This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safety Medical Devices Act of[removed]SMADA[removed]a