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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 K810020
Device Name PANJE VOICE PROSTHESIS
Applicant
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Correspondent
XOMED, INC.
1318 LONEDELL RD.
ARNOLD,  MO  63010
Regulation Number874.3730
Classification Product Code
EWL  
Date Received01/05/1981
Decision Date 02/05/1981
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
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