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Ethicon Eindo-Surgery, LLC K13 1435 EnSeal Tissue Sealing Devices - Premnarket Notification (Traditional)
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Document Date: 2013-11-14 08:33:11

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File Size: 173,32 KB

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City

Cincinnati / /

Company

Enclosure Premarket Notification (Traditional) Ethicon Endo-Surgery LLC / Effectiveness Company Ethicon Endo-Surgery LLC / CQA Regulatory Affairs Portfolio Leader Ethicon Endo-Surgery Inc. / K131435 Trade / Ethicon Eindo-Surgery LLC / /

Event

FDA Phase / /

/

IndustryTerm

subject device / fuirther announcements concerning your device / predicate devices / electronic product / predicate device / surgical devices / coagulation device / tissue sealing devices / Internet address http /

MedicalCondition

chronic survival study vias / MS / /

MedicalTreatment

hysterectomies / Electrocautery / laparoscopic surgery / Surgery / /

Organization

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

Person

Mark N.Melkerson / Marcia Arenlz / Marcia Arentz / /

/

Position

Affairs Portfolio Leader / surgeon / /

Product

K13 1435 EnSeal Tissue Sealing Devices / K13 1435 EnSeal / K13 / /

ProvinceOrState

Ohio / /

Technology

radiation / bipolar electrosurgical technology / /

URL

http /

SocialTag