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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 K914816
Device Name AMERICAN ARTIFICIAL LARYNX
Applicant
Ultravoice, Ltd.
19 E. Central Ave.
Paoli,  PA  19301
Applicant Contact DAVID R BARAFF
Correspondent
Ultravoice, Ltd.
19 E. Central Ave.
Paoli,  PA  19301
Correspondent Contact DAVID R BARAFF
Regulation Number874.3375
Classification Product Code
ESE  
Date Received10/25/1991
Decision Date 02/12/1993
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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