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Dosage forms / Food law / Pharmacology / Infusion set / Premarket approval / Infusion pump / Federal Food /  Drug /  and Cosmetic Act / Medical device / Subcutaneous injection / Medicine / Medical equipment / Food and Drug Administration


Section[removed]k) Summary K Number -K14 APR[removed]
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Document Date: 2014-05-07 12:37:00


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City

Tubing / El Dorado Hills / /

Company

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 / /

ProgrammingLanguage

K / /

ProvinceOrState

Maryland / California / /

Technology

radiation / fundamental scientific technology / /

URL

www.fda.pov/MedicalDevices/ResourcesforYou/indulstry/default.htm / www.fda.pov/MedicalDevices/Safetv/ReportaProblem/default.htmf / http /

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