Division of Postmarket Surveillance / Microbiology Devices Office / Regulatory Affairs Office / National Center for Emerging / Centers for Disease Control and Prevention / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Radiological I-lea Ith Center for Devices and Radiological Health Enclosure / CDRH's office of Surveillance / /
Person
Sally A. Hojvat / John Hobson / / /
Position
DIRECTOR FOR REGULATORY AFFAIRS LABORATORY PREPAREDNESS AND RESPONSE BRANCH NCEZID/DPEI / additional reporter / Director Division / Director / reporter / /
MAY[removed]SION)i Summary This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR[removed]Assigned 510(k) number: