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Surgical oncology / Laparoscopic surgery / Medical equipment / Gynecological surgery / Electrosurgery / Covidien / Hysterectomy / Tubal ligation / Medical device / Medicine / Surgery / Endoscopy


C-3COVIDIEN APR[removed]k) Summary Date summary prepared: [removed]
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Document Date: 2013-05-06 11:18:57


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File Size: 156,18 KB

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City

Boulder / /

Company

Covidien / K130744 Trade / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

/

IndustryTerm

mechanical cutting device / electrosurgical energy / announcements concerning your device / predicate device / coagulation device / manufacturing practice requirements / energy platform / marketed predicate devices / manufacturing practice / energy / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Surgical Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Surgical Devices / New Hampshire Avenue Document Control Center / Device Evaluation Center for Devices and Radiological Health Enclosure / CDRH's office of Surveillance / /

Person

Diane Reed / Silver Spring / /

/

Position

Acting Director / Sr. Regulatory Affairs Product Specialist / surgeon / /

Product

Federal Food / /

ProvinceOrState

Maryland / Colorado / /

Technology

radiation / radio frequency / /

URL

http /

SocialTag