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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 K231204
Device Name Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App
Applicant
Cochlear
10350 Park Meadows Dr.
Centennial,  CO  80124
Applicant Contact Denis DiMartino
Correspondent
Cochlear
10350 Park Meadows Dr.
Centennial,  CO  80124
Correspondent Contact Denis DiMartino
Regulation Number874.3340
Classification Product Code
PFO  
Date Received04/27/2023
Decision Date 08/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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