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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Active Implantable Bone Conduction Hearing System
510(k) Number K190589
Device Name Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
Applicant
Cochlear Americas
13059 E Peakview Ave.
Centennial,  CO  80111
Applicant Contact Laura Blair
Correspondent
Cochlear Americas
13059 E Peakview Ave.
Centennial,  CO  80111
Correspondent Contact Laura Blair
Regulation Number874.3340
Classification Product Code
PFO  
Date Received03/07/2019
Decision Date 07/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT03086135
NCT03509974
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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