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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 K043138
Device Name PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
Applicant
ATOS MEDICAL AB
KRAFTGATAN 8
HORBY,  SE SE-242 22
Applicant Contact EDDY ABERG
Correspondent
ATOS MEDICAL AB
KRAFTGATAN 8
HORBY,  SE SE-242 22
Correspondent Contact EDDY ABERG
Regulation Number874.3730
Classification Product Code
EWL  
Date Received11/12/2004
Decision Date 11/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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