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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 K901503
Device Name ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM
Applicant
Stanton Magnetics, Inc.
101 Sunnyside Blvd.
Plainview,  NY  11803
Applicant Contact BIDWELL, III
Correspondent
Stanton Magnetics, Inc.
101 Sunnyside Blvd.
Plainview,  NY  11803
Correspondent Contact BIDWELL, III
Regulation Number874.3375
Classification Product Code
ESE  
Date Received03/30/1990
Decision Date 06/28/1990
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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