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K123926[removed]k) Summary MAY[removed]
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Document Date: 2013-06-10 14:12:48


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File Size: 112,21 KB

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City

Houston / /

Company

Staples (K07003 1) Biomedical Enterprises Inc. / K123926 Trade / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

/

IndustryTerm

use nickel titanium alloy bone fixation device / Internet address http /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / Food and Drug Administration / CDRH' s office of Surveillance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Mark N. Melkerson Director Division / /

Person

Joshua Scott / Silver Spring / Mark N. Melkerson / Nickel Titanium Alloy (Nitinol) / /

/

Position

Scoff Vice President of Engineering / /

Product

Federal Food / /

ProvinceOrState

Texas / Maryland / /

Technology

radiation / http / /

URL

http /

SocialTag