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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 K924350
Device Name HEARING AID (ALL-IN-THE-EAR)
Applicant
EAR MASTERS, INC.
2039 SOUTH MILL AVE., SUITE D
TEMPE,  AZ  85282
Applicant Contact MICHAEL R KRANE
Correspondent
EAR MASTERS, INC.
2039 SOUTH MILL AVE., SUITE D
TEMPE,  AZ  85282
Correspondent Contact MICHAEL R KRANE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/27/1992
Decision Date 11/16/1992
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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