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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 K873490
Device Name HEARING AID (ALL-IN-THE-EAR)
Applicant
KERR HEARING AID LABORATORY
1555 GARDEN ST.
TITUSVILLE,  FL  32796
Applicant Contact JAMES L KERR
Correspondent
KERR HEARING AID LABORATORY
1555 GARDEN ST.
TITUSVILLE,  FL  32796
Correspondent Contact JAMES L KERR
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/31/1987
Decision Date 11/12/1987
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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