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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 K952263
Device Name PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
Applicant
SIEMENS HEARING INSTRUMENTS, INC.
10 CONSTITUTION AVE.
P.O. BOX 1397
PISCATAWAY,  NJ  08855
Applicant Contact GARY W ROESEL
Correspondent
SIEMENS HEARING INSTRUMENTS, INC.
10 CONSTITUTION AVE.
P.O. BOX 1397
PISCATAWAY,  NJ  08855
Correspondent Contact GARY W ROESEL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/15/1995
Decision Date 06/05/1995
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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