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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 K940638
Device Name PROVOX(TM) VOICE PROSTHESIS
Applicant
Atos Medical AB
P.O. Box 183
Horby, Sweden,  SE SE-24222
Applicant Contact KARL-ERIK KARLSSON
Correspondent
Atos Medical AB
P.O. Box 183
Horby, Sweden,  SE SE-24222
Correspondent Contact KARL-ERIK KARLSSON
Regulation Number874.3730
Classification Product Code
EWL  
Date Received02/14/1994
Decision Date 06/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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