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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name audiometer
510(k) Number K981460
Device Name CUB DIS II DPOAE MEASUREMENT SYSTEM
Applicant
MIMOSA ACOUSTICS, INC.
382 FOREST HILL WAY
MOUNTAINSIDE,  NJ  07092
Applicant Contact PATRICIA S JENG
Correspondent
MIMOSA ACOUSTICS, INC.
382 FOREST HILL WAY
MOUNTAINSIDE,  NJ  07092
Correspondent Contact PATRICIA S JENG
Regulation Number874.1050
Classification Product Code
EWO  
Date Received04/23/1998
Decision Date 05/20/1998
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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