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Health / Pharmaceutical industry / Quality management / Validity / Food law / Medical device / Quality management system / Introducer sheath / Validation / Medicine / Technology / Food and Drug Administration


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 09:21:37


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City

Daniels Way Bloomington / Bloomington / /

Company

K132592 Trade / Terumo / Cook Inc. / 3 Cook Incorporated / 1 PSC Publishing / /

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Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

announcements concerning your device / predicate devices / diagnostic and interventional devices / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /

MedicalTreatment

Catheter / /

Organization

Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Center for Devices and Radiological Health / Cardiovascular 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 / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / CDRH's office of Surveillance / /

Person

Bram D. Zuckerman / Silver Spring / David Lehr / Melissa A. Torres / /

/

Position

Regulatory Affairs Specialist / Director Division / /

Product

Flexor / Federal Food / /

ProvinceOrState

Maryland / Indiana / /

Technology

radiation / /

URL

http /

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