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Psoriasis / Electromagnetic spectrum / Ultraviolet / Vitiligo / Light therapy / Atopic dermatitis / Eczema / Dermatitis / UV-B lamps / Autoimmune diseases / Health / Medicine


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
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Document Date: 2014-11-12 09:21:41


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City

Dempster Drive Coralville / Coralville / /

Company

MedTek Lighting Inc. / AEGIS Regulatory Incorporated / 12V Power Adapter 10 Narrowband UVB Steel / K134009 Trade / EMC / Mobile/Versa Lite (Medtek Lighting) Predicate Chart Device Company / Philips / 60Hz Full Body Steel / 1 PSC Publishing / /

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Event

FDA Phase / /

Facility

Depot St. Hudson Falls / New Hampshire Avenue Document Control Center / /

IndustryTerm

phototherapy device / predicate device / manufacturing practice requirements / cited predicate device / enclosed metal / electrical lighting systems / manufacturing practice / metal cabinet / Internet address http /

MedicalCondition

atopic dermatitis / psoriasis / vitiligo / vitiligo and atropic dermatitis / dermatologic disorders / eczema / diagnosed skin disorders / /

MedicalTreatment

radiation therapy / phototherapy / /

Organization

Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Federal Trade Commission / F.A.C.S. Director Division / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / CDRH’s office of Surveillance / Occupational Safety and Health Administration / UV Biotek Single Panel Unit / Surgical Devices Office / Device Evaluation 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 / /

Person

Silver Spring / Susan Anthoney-De Wet / Robert T. Wagner / Binita S. Ashar / Gary Richardson / /

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Position

General / /

Product

Federal Food / /

ProvinceOrState

Maryland / Iowa / /

Technology

radiation / /

URL

http /

SocialTag