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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Larynx, Artificial (Battery-Powered)
510(k) Number K831127
Device Name INTRA-ORAL ARTIFICIAL LARYNX
Applicant
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Correspondent
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Regulation Number874.3375
Classification Product Code
ESE  
Date Received04/06/1983
Decision Date 07/28/1983
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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