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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Group And Auditory Trainer
510(k) Number K832190
Device Name METAVOX MV-1000 AUDITORY TRAINER
Applicant
Metavox, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Metavox, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.3320
Classification Product Code
EPF  
Date Received07/08/1983
Decision Date 09/12/1983
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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