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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 K843574
Device Name HEARING AID - ALL IN THE EAR
Applicant
Auralogics Lab
2675 Bechelli Lane
Suite 7
Redding ,  CA  96002 -
Applicant Contact RICHARD L HILL
Correspondent
Auralogics Lab
2675 Bechelli Lane
Suite 7
Redding ,  CA  96002 -
Correspondent Contact RICHARD L HILL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/11/1984
Decision Date 12/11/1984
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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