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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 K891248
Device Name BEHIND-THE-EAR HEARING AID MODEL 304 PP-AGC-I
Applicant
SIEMENS HEARING INSTRUMENTS, INC.
10 CORPORATE PLACE SOUTH
CORPORATE PARK 287
PISCATAWAY,  NJ  08854
Applicant Contact L BRANDERBIT
Correspondent
SIEMENS HEARING INSTRUMENTS, INC.
10 CORPORATE PLACE SOUTH
CORPORATE PARK 287
PISCATAWAY,  NJ  08854
Correspondent Contact L BRANDERBIT
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/08/1989
Decision Date 03/29/1989
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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