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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 K921656
Device Name LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE
Applicant
Siemens Hearing Instruments, Inc.
10 Constitution Ave.
P.O. Box 1397
Piscataway,  NJ  08855
Applicant Contact LAURA S LIDDLE
Correspondent
Siemens Hearing Instruments, Inc.
10 Constitution Ave.
P.O. Box 1397
Piscataway,  NJ  08855
Correspondent Contact LAURA S LIDDLE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/07/1992
Decision Date 05/08/1992
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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