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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 K882678
Device Name ITE HEARING AID, SIEMENS MODEL 007, WITH TELOS
Applicant
SIEMENS HEARING INSTRUMENTS, INC.
10 CORPORATE PLACE SOUTH
CORPORATE PARK 287
PISCATAWAY,  NJ  08854
Applicant Contact LEO F HARKINS
Correspondent
SIEMENS HEARING INSTRUMENTS, INC.
10 CORPORATE PLACE SOUTH
CORPORATE PARK 287
PISCATAWAY,  NJ  08854
Correspondent Contact LEO F HARKINS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/28/1988
Decision Date 09/22/1988
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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