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Food and Drug Administration / Catheters / Percutaneous / Port / Medical device / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Medicine / Medical technology / Medical equipment


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
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Document Date: 2015-01-14 16:52:59


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File Size: 155,29 KB

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City

Bloomington / /

Company

Cook Incorporated / Jennifer Richardson Cook Incorporated / K140085 Trade / 1 PSC Publishing / /

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Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

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

MarketIndex

Set 510 / /

Organization

Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Division of Reproductive / 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 / Reproductive / Gastro-Renal / and Urological Devices Office / /

Person

Vance Percutaneous Malecot Nephrostomy Catheter / Silver Spring / Benjamin R. Fisher / Herbert P. Lerner / Jennifer Richardson / /

/

Position

Director / /

Product

Federal Food / /

ProvinceOrState

Maryland / Indiana / /

Technology

radiation / /

URL

http /

SocialTag