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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 K854158
Device Name RESNICK EMITTER, ARTIFICIAL LARYNX
Applicant
Dynamed Audio, Inc.
R.D. 1 Box 415a
Natrona Heights,  PA  15065
Applicant Contact JOSEPH A RESNICK
Correspondent
Dynamed Audio, Inc.
R.D. 1 Box 415a
Natrona Heights,  PA  15065
Correspondent Contact JOSEPH A RESNICK
Regulation Number874.3375
Classification Product Code
ESE  
Date Received10/11/1985
Decision Date 12/13/1985
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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