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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 K973927
Device Name HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
Applicant
Hyunjae Corp.
8 S. End Plaza
New Milford,  CT  06776
Applicant Contact DAN MODICA
Correspondent
Hyunjae Corp.
8 S. End Plaza
New Milford,  CT  06776
Correspondent Contact DAN MODICA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/15/1997
Decision Date 12/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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