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Medical ultrasound / Medical equipment / Food law / Medical device / Ultrasound / Medical ultrasonography / Premarket approval / Center for Devices and Radiological Health / Title 21 of the Code of Federal Regulations / Medicine / Medical physics / Food and Drug Administration


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Document Date: 2013-04-11 12:53:57

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File Size: 130,83 KB

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City

FREMONT CA / Fremont / /

Company

iLab Ultrasound Imaging System / Boston Scientific Corporation / Smith Senior Regulatory Affairs Specialist Boston Scientific Corp. / 2 Boston Scienitific Boston Scientific Corporation / Effectiveness Boston Scientific Corporation / In Vitro Diagnostics / Radiological Health Enclosure Boston Scientific Corporation / K130243 Trade / /

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Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

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IndustryTerm

basic diagnostic tool / real time viewing / announcements concerning your device / predicate device / manufacturing practice requirements / Internet address http2 /

MedicalTreatment

CPR / angioplasty / atherectomy / /

Organization

Radiological Health Office / Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / CDRH 's office of Surveillance / New Hampshire Avenue Document Control Center / /

Person

Lori R. Smith Sr. / Janine Morris / /

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Position

Sr. Regulatory Affairs Specialist / Director / Division / iLabTM Ultrasound Imaging System General Information Manufacturer / /

Product

Federal Food / /

ProvinceOrState

Maryland / California / /

Technology

Design verification / radiation / Diagnostic Imaging System / Ultrasound / same fundamental scientific technology / /

URL

www.fda.gzov/AboutFDA/CenteisOffices/CDRH/CDRH-Offices/ucm / www.fda.Qov/MedicalDevices/Resoui-cesforYou/Industry/default.htm / http /

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