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


K133314 Page 1 of[removed]k) Summary
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Document Date: 2014-01-14 08:01:42

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File Size: 131,16 KB

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City

Cincinnati / /

Company

K1333 14 Trade / Summary Company Ethicon Endo-Surgery LLC / RAG Senior Regulatory Affairs Associate Ethicon Endo-Surgery Inc. / EMC / /

/

IndustryTerm

steel scalpels / memory chip / Internet address http /

MedicalCondition

minimal thermal injury / chronic survival studies / /

MedicalTreatment

tissue incisions / Surgery / /

Organization

Division of Postmarket Surveillance / F.A.C.S. For Acting Director Division of Surgical Devices / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / FDA / Division of Small Manufacturers / International and Consumer Assistance / Division of Surgical Devices / CDRH's office of Surveillance / /

Person

Brian Godwin / Ill / Binita S.Ashar / /

/

Position

Prime Minister / /

ProvinceOrState

Ohio / /

Technology

radiation / lasers / EEPROM memory chip / Adaptive Tissue Technology / http / power output algorithm / /

URL

www.fda.pnov/MedicaiDevices / http /

SocialTag