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APRO04 2014 Traditional 510(k) 510(k) Summary Bard Medical Division C.R. Bard, Inc.
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Document Date: 2014-05-07 12:36:19


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File Size: 125,90 KB

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City

Covington / /

Company

C.R. Bard Inc. / Medical Division C.R. Bard Inc. / K133470 Trade / Coloplast A/s / EZC Legally / /

Event

FDA Phase / /

/

IndustryTerm

subject device / health cure products / announcements concerning your device / predicate device / manufacturing practice requirements / Internet address httn /

Organization

Division of Postmarket Surveillance / RAC Regulatory Affairs Project Manager Bard Medical Division / office of Device Evaluation / Division of Reproductive / FDA / Division of Small Manufacturers / International and Consumer Assistance / Device Evaluation Center for Devices and Radiological Health Enclosure Traditional / CDRI-I's office of Surveillance / Reproductive / Gastro-Renal / and Urological Devices Office / /

Person

Benjamin R. Fisher / Michele Davis / /

/

Position

CPA / Director / RAC Regulatory Affairs Project Manager / Manager 8195 Industrial Blvd. Covington / /

Product

Federal Food / /

ProvinceOrState

Maryland / Georgia / /

Technology

radiation / /

URL

www.fda.2ov/Medicalevices/ResourcsforYou/IndustrV/defaulthtm / www.fda.uov/MedicalDevices/Safet/Re~rtaProblem/default.tml / http /

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