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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 K844728
Device Name ADVANCED HEARING INSTRUMENTS - HEARING AIDS
Applicant
Advanced Hearing Instruments
1 Fairway Dr.
Novato,  CA  94947
Applicant Contact HOWARD L HAIT
Correspondent
Advanced Hearing Instruments
1 Fairway Dr.
Novato,  CA  94947
Correspondent Contact HOWARD L HAIT
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/04/1984
Decision Date 01/23/1985
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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