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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 K903760
Device Name MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM
Applicant
SIEMENS HEARING INSTRUMENTS, INC.
10 CONSTITUTION AVE.
P.O. BOX 1397
PISCATAWAY,  NJ  08855
Applicant Contact PAMELA L BRANDERBIT
Correspondent
SIEMENS HEARING INSTRUMENTS, INC.
10 CONSTITUTION AVE.
P.O. BOX 1397
PISCATAWAY,  NJ  08855
Correspondent Contact PAMELA L BRANDERBIT
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/20/1990
Decision Date 10/05/1990
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
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