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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name self-fitting air-conduction hearing aid, prescription
510(k) Number K213424
Device Name Jabra Enhance Plus
GN Hearing A/S
Lautrupbjerg 7
Ballerup,  DK DK-2750
Applicant Contact Lars Hagander
GN Hearing A/S
Lautrupbjerg 7
Ballerup,  DK DK-2750
Correspondent Contact Lars Hagander
Regulation Number874.3325
Classification Product Code
Subsequent Product Code
Date Received10/21/2021
Decision Date 01/19/2022
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