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Medical physics / Food law / Medical equipment / Brachytherapy / Medical device / Radiation therapy / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Medicine / Food and Drug Administration / Radiation oncology


EM ERGOOGROUP RADIRDYNE MAY
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Document Date: 2012-06-11 00:35:07


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City

Houston / Austin / Third Floor AUSTIN TX / /

Company

K120344 Trade / Emergo Group Inc. Company / RadiaDyne LLC / R. Goldman Senior Consultant Emergo Group Inc. / RAFINGRADIAIN EY Flexible Treatment Area 9GROUP / /

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Event

FDA Phase / /

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IndustryTerm

announcements concerning your device / balloon device / predicate devices / Internet address http /

Organization

Division of Postmarket Surveillance / In Vitro Diagnostic Device Evaluation and Safety Center for Devices / Food and Drug Administration / office of Device Evaluation / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / Radiological Devices Office / /

Person

Silver Spring / Stuart R. Goldman / ROU P RADIRDYNG RSO / /

/

Position

ing Director Division / SUMMARY Submission Correspondent / physician / Consultant / /

Product

Alatusg Vaginal Balloon Packing System / RadiaPak Tm Device / Food / /

ProvinceOrState

Texas / Maryland / /

Technology

radiation / x-ray / tomography / /

URL

www.emergogroup.com / http /

SocialTag