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og[removed]k) Summary Versa~let 11Hydrosurgery System Submitter:
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Document Date: 2011-09-26 00:30:50

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File Size: 148,25 KB

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City

St. Petersburg / /

Company

Smith &Nephew Inc. / VersaJet Hydrosurgery System Smith &Nephew Inc. / K1 10958 Trade / /

IndustryTerm

manufacturing practice requirements / Internet address Sirely / surgical site / marketed predicate devices / manufacturing practice / surgical applications / announcements concerning your device / /

Organization

FDA / Division of Postmarket Surveillance / Division of Small Manufacturers / International and Consumer Assistance / Surgical / Orthopedic and Restorative Devices Office / CDRHI's office of Surveillance / office of Compliance / Mark N. Melkerson Director Division of Surgical / office of Device Evaluation / Center for Devices / /

Person

Laura D. Reynolds / Mark N. Melkerson / Silver Spring / /

/

Position

Director / Regulatory Affairs / Director Regulatory Affairs / /

ProgrammingLanguage

FL / /

ProvinceOrState

Maryland / Florida / /

Technology

Design verification / radiation / http / ADO / /

SocialTag