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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name face plate hearing aid
510(k) Number K961593
Device Name INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
Applicant
SEGI HEARING AID CO.
24 FIFTH AVE.
NEW YORK,  NY  10011
Applicant Contact LEO WEINBERGER, ESQ.
Correspondent
SEGI HEARING AID CO.
24 FIFTH AVE.
NEW YORK,  NY  10011
Correspondent Contact LEO WEINBERGER, ESQ.
Regulation Number874.3300
Classification Product Code
LRB  
Date Received04/24/1996
Decision Date 11/07/1996
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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