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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 K220922
Device Name Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
Applicant
Cochlear Americas
10350 Park Meadows Dr.
Centennial,  CO  80124
Applicant Contact Samata Veluvolu
Correspondent
Cochlear Americas
10350 Park Meadows Dr.
Centennial,  CO  80124
Correspondent Contact Samata Veluvolu
Regulation Number874.3340
Classification Product Code
PFO  
Date Received03/31/2022
Decision Date 07/27/2022
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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