SOPRO-Acteon Group / 0U Rick Rosati Quality Manager Satelec Acteon Group / In Vitro Diagnostics / K140013 Trade / 1 PSC Publishing / / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / /
IndustryTerm
announcements concerning your device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /
NaturalFeature
MT LAUREL NJ / /
Organization
Radiological Health Office / Division of Postmarket Surveillance / Division of Industry and Consumer Education / HUMAN SERVICES Public Health Service / Food and Drug Administration / Janine M. Morris Director Division / Center for Devices and Radiological Health / 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 / /
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service __________________________________________________________________________________________________________________________ SOPRO-Acteon Group