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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 K890271
Device Name ALPHA MODEL I ITE HEARING AID
Applicant
Alpha Instruments, Inc.
611 S. Main
Sikeston,  MO  63801
Applicant Contact BETTY ROBERTS
Correspondent
Alpha Instruments, Inc.
611 S. Main
Sikeston,  MO  63801
Correspondent Contact BETTY ROBERTS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/18/1989
Decision Date 06/16/1989
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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