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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 K971244
Device Name PROVOX 2 VOICE PROSTHESIS SYSTEM
Applicant
ATOS MEDICAL AB
P.O. BOX 183
HORBY, SWEDEN,  SE SE-24222
Applicant Contact EDDY ABERG
Correspondent
ATOS MEDICAL AB
P.O. BOX 183
HORBY, SWEDEN,  SE SE-24222
Correspondent Contact EDDY ABERG
Regulation Number874.3730
Classification Product Code
EWL  
Date Received04/03/1997
Decision Date 06/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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