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510(k) Summary K121345 Halifax Biomedical Inc[removed]Route 1%, Mabou Nova Scotia, Canada, BOE 1X0 Phone +[removed]
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Document Date: 2012-07-06 14:45:24

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File Size: 440,24 KB

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Company

Canon / Sedecal Digital / K121345 Trade / Digital Radiographic Systems / The SR Suite / Halifax Biomedical Inc. / EMC / The Sedecal Millenium / P.E. Principal Engineer Kamm & Associates / Roentgen Acquisition Software / Summary K121345 Halifax Biomedical Inc. / /

Facility

Ravello Court / /

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IndustryTerm

announcements concerning your device / predicate devices / Software validation / manufacturing practice requirements / Internet address http /

Organization

Division of Postmarket Surveillance / Center for Devices and Radiological Health Enclosure Indications for Use / Food and Drug Administration / CDRH' s office of Surveillance / United Nations / NAPLES FL / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Bank of England / Radiological Devices Office / /

Person

Mo Owl / Daniel Kamm / Silver Spring / Pixel / Chad Munro / /

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Position

ing Director Division / CEO President / technician / /

ProgrammingLanguage

FL / J / /

ProvinceOrState

Maryland / /

Technology

X-ray / X-ray system / /

URL

http /

SocialTag