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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 K911811
Device Name SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID
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 Received04/23/1991
Decision Date 06/26/1991
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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