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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 K884583
Device Name BTE HEARING AID SIEMENS MODEL 284PP-ASP
Applicant
Siemens Hearing Instruments, Inc.
10 Corporate Pl. S.
Corporate Park 287
Piscataway,  NJ  08854
Applicant Contact LEO F HARKINS
Correspondent
Siemens Hearing Instruments, Inc.
10 Corporate Pl. S.
Corporate Park 287
Piscataway,  NJ  08854
Correspondent Contact LEO F HARKINS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/02/1988
Decision Date 01/18/1989
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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