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Food and Drug Administration / Assistive technology / Hearing aids / Food law / Cochlear Baha / Hearing impairment / Medical device / Federal Food /  Drug /  and Cosmetic Act / Sensorineural hearing loss / Medicine / Health / Otology


Ad DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service[removed]New Hurnpsire, Avenue
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Document Date: 2013-12-09 11:45:22


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Company

K131240 Trade / /

Event

FDA Phase / /

IndustryTerm

announcements concerning your device / manufacturing practice requirements / sound processor / marketed predicate devices / manufacturing practice / Internet address http /

MedicalCondition

mixed hearing loss / unilateral sensorineural deafness / Single-sided deafness / mixed and single sided deafness / /

Organization

HUMAN SERVICES Public Health Service / Center for Devices and Radiological Health / office of Compliance / FDA / Division of Small Manufacturers / International and Consumer Assistance / Division of Ophthalmic and Ear / DEPARTMENT OF HEALTH / Division of Ophthalmic / Device Evaluation Center for Devices and Radiological Health Enclosure / Division of Posimarket Surveillance / CDRH's office of Surveillance / Ear / Nose and Throat Devices Office / /

Person

Eric A.Mann / Baha Implant / Scan Bundy / Malvina B. Eydelman / Sean Bundy / /

/

Position

Quality Director / Director 13059 East Peakview Avenue Centennial / Director / M.D. Director / /

Product

SSD / Federal Food / 2I1CFR / /

ProvinceOrState

Maryland / Colorado / /

Technology

radiation / external Sound Processor / 00 sound processor / BP1IO0 sound processor / ADO / /

URL

www.fda.gov/AboutFDA/CentersOffices/CDRH-/CDPHOffices/ucm / www.fda.pov/MedicalDevices/Safetv/ReportaProblem/default.htm / http /

SocialTag