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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 K910325
Device Name AHL, ITE MODEL AMERICAN
Applicant
BOB BARE HEARING AID REPAIR
14232 MARSH LANE, SUITE 324
DALLAS,  TX  75234
Applicant Contact ROBERT C BARE
Correspondent
BOB BARE HEARING AID REPAIR
14232 MARSH LANE, SUITE 324
DALLAS,  TX  75234
Correspondent Contact ROBERT C BARE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/24/1991
Decision Date 04/15/1991
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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