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Food law / Skull / Stitches / Medical device / Medical equipment / Surgical suture / Center for Devices and Radiological Health / Premarket approval / Suture / Medicine / Health / Food and Drug Administration


Document Date: 2012-02-27 00:31:31


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City

Scottsdale / /

Company

Suture Anchor Al Response Cayenne Medical Inc. / Smith & Nephew / K1 12960 Trade / The Cayenne Medical Inc. / Al Response Cayenne Medical Inc. / Summary Cayenne Medical Inc. / /

Currency

pence / /

/

IndustryTerm

fuirther announcements concerning your device / predicate device / manufacturing practice requirements / anchor device / marketed predicate devices / manufacturing practice / Internet address / apredicate device / /

Organization

Division of Postmarket Surveillance / Mark N. Mekr Director Division of Surgical / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / *DEPARTMENT Public Health Service OF HEALTH / Division of Surgical / Orthopedic / and Restorative Devices / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / Surgical / Orthopedic and Restorative Devices Office / /

Person

Kereshmeh Shahriari / Silver Spring / Mark N. Mekr / Kereshmeh Shabriari / /

/

Position

Official / /

Product

LabraLinkTM Suture Anchor / /

ProvinceOrState

Maryland / Arizona / /

Technology

radiation / ADO / /

URL

www.fdaigov/MedicalDevices/Safety/Rev~ortaProblemh/defaulthtm / http /

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