K 140131 Trade / The EMED Technologies Corporation / EMED Technologies Corporation C / Set (K020530) Submitter Peter Kollings EMED Technologies Corporation / /
Event
FDA Phase / /
Facility
General Hospital / /
IndustryTerm
prescription device / announcements concerning your device / predicate devices / predicate device / manufacturing practice requirements / predicate product / Internet address httto /
MedicalCondition
sterility assurance level / /
Organization
Division of Postmarket Surveillance / Hawks Flight Court / Center for Devices and Radiological Health / office of Compliance / office of Surveillance / FDA / General Hospital / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / Respiratory / Infection Control and Dental Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / M.S. Acting Director Division of Anesthesiology / Environmental Protection Agency / /
Person
Keith / Peter Kollings / / /
Position
General Information Classification Class / Bonding Agent / Director Regulatory Affairs and Quality Assurance / ABS Bonding Agent / /
Product
Q Subcutaneous Tissue Infusion Set / Federal Food / /