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Food law / Skull / Stitches / Injuries / Surgical suture / Suture / Medical device / Federal Food /  Drug /  and Cosmetic Act / Premarket approval / Medicine / Health / Food and Drug Administration


Module A - Administration CO~tllK n[removed]ConceptBuInvaM
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Document Date: 2013-08-06 11:28:26


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City

Concept Boulevard Largo / /

Company

ConMed / Module A - Administration CO / Y.Knotm All-Suture Anchor Linvatec Corporation / K131035 Trade / Unvatec Corporation / 9Apri1 2013 A. Submitter Linvatec Corporation / /

Event

FDA Phase / /

Facility

Dnzg Administration Documnent Control Center / /

/

IndustryTerm

transportation / soft-tissue fixation devices / announcements concerning your device / manufacturing practice requirements / stainless steel shaft / marketed predicate devices / manufacturing practice / Internet address htp /

Organization

Orthopedic Devices Office / Division of Postmarket Surveillance / For Mark N. Melkerson Director Division / office of Device Evaluation / HUMAN SERVICES S'4 Public Health Serice and Dnzg Administration Documnent Control Center / FDA / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / /

Person

Joy Lovett / Mark N. Melkerson / /

/

Position

Regulatory Affairs Specialist / flexible driver / /

Product

ConMed Linvatec 1111779 PagelI / Federal Food / /

ProgrammingLanguage

FL / /

ProvinceOrState

Maryland / Florida / /

Technology

radiation / /

URL

www.fda.gov/MedicalDevices/Safet/ReportaProblemh/default.htm / www.fda.pov/MedicaDevices/ResourcsforYou/Idustr/default.html / www.fda.Rov/MedicaDevices/ResourcesforYouIn~dustry/default.htm / /

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