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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 K964683
Device Name DIGIFOCUS ITE
Applicant
OTICON, INC.
29 SCHOOLHOUSE RD.
SOMERSET,  NJ  08873
Applicant Contact PREBEN BRUNVED
Correspondent
OTICON, INC.
29 SCHOOLHOUSE RD.
SOMERSET,  NJ  08873
Correspondent Contact PREBEN BRUNVED
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/22/1996
Decision Date 12/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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