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Polyp / SNARE / Medical device / Federal Food / Drug / and Cosmetic Act / Medicine / Surgical procedures / Gynaecology


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Document Date: 2013-12-09 11:45:29

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City

Way Marlborough / /

Company

Boston Scientific Corporation / Submiitter Boston Scientific Corporation / K131700 Trade / Olympus / Single-Use Polypectomy Snares Profile / Rotatable Snares / /

Event

FDA Phase / /

Facility

Food and Drug Administration Document Control Center / /

/

IndustryTerm

announcements concerning your device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / manufacturing processes / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / Gastro-Renal / and Urological Devices Office / office of Device Evaluation / Division of Reproductive / and Drug Administration Document Control Center / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / /

Person

Janis F. Traranto / Benjamin R. Fisher / /

/

Position

Director / Senior Regulatory Affairs Specialist / /

Product

Polypectomy Snares / M-16 / Federal Food / K955650 / K94 / K13 / 2Q13 / /

ProvinceOrState

North Dakota / Massachusetts / /

Technology

radiation / /

URL

http /

SocialTag