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Ku30J2J2 510(K) Summary for Whirlwind Roughffider® Manual Wheelchair
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Document Date: 2011-02-17 14:36:48

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File Size: 164,15 KB

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City

San Francisco / Tracking / /

Company

Invacare / K103212 Trade / /

Event

FDA Phase / /

Facility

Facility Registration Number / /

/

IndustryTerm

carbon steel tubing / carbon steel / announcements concerning your device / predicate device / manufacturing practice req uirements / marketed predicate devices / Internet address littp /

Organization

Division of Postmarket Surveillance / PT JL / office of Compliance / FDA / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic / and Restorative Devices Office / Mark N. Melkerson Director Division of Surgical / CDRH's office of Surveillance / Center for Devices / /

Person

Marc Krizack / Mark N. Melkerson / /

/

Position

Executive Director / rear wheel position forward / chair at the caster housing / Director 1600 Holloway Avenue / /

Product

Federal Food / JN-321 / /

ProvinceOrState

California / /

Technology

radiation / http / /

URL

www.fda.gov/MedicalDevices/ResourcesforYou/Industi-y/default.htm / http /

SocialTag