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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 K220403
Device Name Vibe SF Self-Fitting Hearing Aid
Applicant
Wsaud A/S
Nymollevej 6
Lynge,  DK 3540
Applicant Contact Kristine Klitgaard Pedersen
Correspondent
Hogan Lovells US LLP
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number874.3325
Classification Product Code
QDD  
Date Received02/11/2022
Decision Date 08/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT04972162
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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