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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 K893574
Device Name SIEMENS MODEL 284 PP-AGC
Applicant
Siemens Hearing Instruments, Inc.
10 Corporate Pl. S.
Corporate Park 287
Piscataway,  NJ  08854
Applicant Contact PAMELA BRANDERBIT
Correspondent
Siemens Hearing Instruments, Inc.
10 Corporate Pl. S.
Corporate Park 287
Piscataway,  NJ  08854
Correspondent Contact PAMELA BRANDERBIT
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/09/1989
Decision Date 05/21/1990
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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