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Medical equipment / Pharmaceuticals policy / Medical device / Medical technology / Title 21 of the Code of Federal Regulations / Center for Devices and Radiological Health / Premarket approval / Federal Food / Drug / and Cosmetic Act / Adenoidectomy / Medicine / Food and Drug Administration / Food law


Document Date: 2013-05-06 11:19:37

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City

Austin / /

Company

ArthroCare Coblator IQ / HUMAN SERVICES Arthrocare Corporation / ArthroCare Corporation / K123353 Trade / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

Internet address http /

MedicalCondition

Tumors / Tumors Over-The / Cysts / Laryngeal Lesion Debulking Papilloma Keloids / Nasal Airway Obstruction / /

MedicalTreatment

surgery / /

Organization

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

Person

Neck / Silver Spring / Mitchell Dhority / /

/

Position

General Information Submitter Name / Vice President / Clinical and Regulatory Affairs Date / Adenoidectomy Head / Vice President / Clinical and Regulatory Affairs / CIQ Controller / Controller / Head / /

Product

Federal Food / 2I1CFR / /

ProvinceOrState

Texas / Maryland / /

Technology

radiation / /

URL

http /

SocialTag