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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 K943380
Device Name SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS
Applicant
Siemens Hearing Instruments, Inc.
10 Constitution Ave.
Piscataway,  NJ  08855
Applicant Contact GARY W ROESEL
Correspondent
Siemens Hearing Instruments, Inc.
10 Constitution Ave.
Piscataway,  NJ  08855
Correspondent Contact GARY W ROESEL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/13/1994
Decision Date 01/05/1995
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
Predetermined Change
Control Plan Authorized		 No
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