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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name masker, tinnitus
510(k) Number K011366
FOIA Releasable 510(k) K011366
Device Name CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
Applicant
SIEMENS HEARING INSTRUMENTS, INC.
10 CONSTITUTION AVE.
P.O. BOX 1397
PISCATAWAY,  NJ  08855
Applicant Contact DAVE SLAVIN
Correspondent
SIEMENS HEARING INSTRUMENTS, INC.
10 CONSTITUTION AVE.
P.O. BOX 1397
PISCATAWAY,  NJ  08855
Correspondent Contact DAVE SLAVIN
Regulation Number874.3400
Classification Product Code
KLW  
Date Received05/04/2001
Decision Date 06/01/2001
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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