K140041 Trade / QQ 0LQ Business Development Manager GENORAY America Inc. / OEC 9900 Elite K082781 GENORAY Co. Ltd / In Vitro Diagnostics / GE Healthcare / DQE / GENORAY Co. Ltd. / EMC / GENORAY Co. Ltd. Trade / Official Correspondent / GENORAY America Inc. / 1 PSC Publishing / /
Country
United States / Korea / /
Currency
VND / / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
physicianĜs applications / image display monitors and recording devices / announcements concerning your device / predicate devices / predicate device / fundamental technology / manufacturing practice requirements / marketed predicate devices / manufacturing practice / x-ray imaging components / Internet address http /
OperatingSystem
Genera / /
Organization
Radiological Health Office / Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Janine M. Morris Director Division / Radiological Health Center for Devices / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / CDRH’s office of Surveillance / /
Person
Silver Spring / Janine M. Morris / Vert / NEMA PS / / /
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