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APR 510(k) SUMMARY This sunmnary of 510(k) safety and effectiveness infornation is being submitted in accordance with the requirements of 21 CFR[removed]Submitter Information: US Medical Innovations, LLC
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Document Date: 2011-05-30 00:43:02


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File Size: 152,98 KB

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City

New Brighton / Lakeland / /

Company

US Medical Innovations LLC / Canady Technology LLC / K100669 Trade / TUV SUD America Inc. / Krista Oakes Senior Regulatory Consultant Emergo Group Inc. / MCa / /

Event

Reorganization / FDA Phase / /

/

IndustryTerm

monopolar argon gas / Internet address http /

MedicalTreatment

general surgery / /

Organization

Electrosurgery Unit / Center for Devices and Radiological HeIalth / Food and Drug Administration / office of Compliance / office of Device Evaluation / Argon Plasma Coagulation Unit / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic and Restorative Devices Office / Mark N. Melkerson Director Division of Surgical / Center for Devices / Canady Plasma Electrosurgery Unit / /

Person

Dawn TibodeaU / Restorative / Jerome Canady / Mark N. Melkerson / /

/

Position

physician / General / Application Correspondent / /

Product

Canady Plasma Probes / Federal Food / /

ProvinceOrState

Minnesota / Maryland / Florida / /

Technology

radiation / http / /

URL

http /

SocialTag