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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Laryngeal (Taub)
510(k) Number K141380
Device Name PROVOX FREEHANDS FLEXIVOICE
Applicant
Atos Medical AB
Kraftgatan 8
Horby,  SE SE-242 22
Applicant Contact FERENC DAHNER
Correspondent
Atos Medical AB
Kraftgatan 8
Horby,  SE SE-242 22
Correspondent Contact FERENC DAHNER
Regulation Number874.3730
Classification Product Code
EWL  
Date Received05/27/2014
Decision Date 09/26/2014
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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