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Shoulder / SLAP tear / Ligament / Elbow / Knee / Fibular collateral ligament / Triangular fibrocartilage / Medical device / Premarket approval / Anatomy / Medicine / Biology


qPARCU r\AeOICAL,LC FB0521 510(k) Summary
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Document Date: 2013-03-08 15:17:53

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File Size: 156,46 KB

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City

Parkland Dr Sarasota / Sarasota / Dr Sarasota / /

Company

K122805 Trade / Biomet / AeOICALLC / Parcus Medical LLC / /

Event

FDA Phase / /

Facility

Newv Hampshire Avenue Document Control Center / /

/

IndustryTerm

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

MedicalTreatment

Rotator Cuff Repair / /

Organization

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

Person

Anton E. Dmitriev / Mark N. Melkerson / Paul Vagts / /

/

Product

Federal Food / 2I1CFR / /

ProgrammingLanguage

FL / /

ProvinceOrState

Wisconsin / Maryland / Florida / /

Technology

radiation / Sports Medicine / /

URL

http /

SocialTag