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510(k) Summary (April 5, 2012): Company: Elsertech, LLCAP Contact:
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Document Date: 2012-05-28 00:33:46


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City

Diego / San Diego / /

Company

Eisertech LLC / Synthes / Eistertech LLC / Blackstone Medical Inc. / K1 13170 Trade / California 92103 Substantial Equivalence Elsertech LLC / /

Event

FDA Phase / /

IndustryTerm

internal fixation device / Internet address http /

Organization

Division of Postmarket Surveillance / HUMAN SERVICES Public Health Service / Food and Drug Administration / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Division of Small Manufacturers / International and Consumer Assistance / Surgical / Orthopedic / and Restorative Devices office of Device Evaluation Cenier for Devices and Radiological Health Enclosure / DEPARTMENT OF HEALTH / Mark N. Melkerson Director Division of Surgical / /

Person

Silver Spring / Lukas Eisermann / Mark N. Melkerson / /

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Product

Federal Food / /

ProvinceOrState

Maryland / /

Technology

radiation / http / same basic technology / /

URL

http /

SocialTag