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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, air-conduction, prescription
510(k) Number K833152
Device Name METAVOX MV-1000 HEARING AID
Applicant
METAVOX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
METAVOX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/15/1983
Decision Date 12/08/1983
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
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