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Medical device / Premarket approval / Title 21 of the Code of Federal Regulations / Center for Devices and Radiological Health / Quality management system / Electrosurgery / Wand / Medicine / Health / Food and Drug Administration


K[removed]Page I of[removed]k) Summary AribroCare® Corporation TURBINATORTM WAND
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Document Date: 2013-08-06 11:27:47


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City

Austin / /

Company

ArthroCare Corporation / ArthroCare Corporation C / ArthroCare Coblator 11 System / PhD / /

Event

FDA Phase / /

IndustryTerm

energy source / Internet address litrn//www.da.Qiov/MedicalDevicCs/RsotII'CCsI'rYotI/lIiLlUStfl/deiatilt.htm / chemical composition / predicate device / tile device / coagulation device / manufacturing practice requirements / market thle device / marketed predicate devices / manufacturing practice / electrosurgical device / conductive media delivery / /

Organization

Division of Postmarket Surveillance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / FDA / Mark N. Melkerson Acting Director Division / Surgical Devices Office / Division of Small Manufacturers / International and Consumer Assistance / Division of Surgical Devices / CDRH's office of Surveillance / /

Person

Mark N.Mel / Dawson / Mitchell Dhority / /

/

Position

Manager / Regulatory Affairs Contact Person / Ohority Vice President / General Information Submitter Name / Vice President / Clinical and Regulatory AffTairs / Controller / /

Product

Turbinator Wand / Federal Food / /

ProgrammingLanguage

J / K / /

ProvinceOrState

Texas / /

TVStation

WAND / /

Technology

radiation / /

URL

www.da.Qiov/MedicalDevicCs/RsotII'CCsI'rYotI/lIiLlUStfl/deiatilt.htm / /

SocialTag