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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 K944174
Device Name LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
Applicant
Siemens Hearing Instruments, Inc.
10 Constitution Ave.
Piscataway,  NJ  08855
Applicant Contact GARY ROESEL
Correspondent
Siemens Hearing Instruments, Inc.
10 Constitution Ave.
Piscataway,  NJ  08855
Correspondent Contact GARY ROESEL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/26/1994
Decision Date 12/27/1994
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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