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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 K982878
Device Name EARSCAN 3
Applicant
Micro Audiometrics Corp.
2200 So.Ridgewood Ave.
South Daytona,  FL  32119 -3018
Applicant Contact JASON R KELLER
Correspondent
Micro Audiometrics Corp.
2200 So.Ridgewood Ave.
South Daytona,  FL  32119 -3018
Correspondent Contact JASON R KELLER
Regulation Number874.1050
Classification Product Code
EWO  
Date Received08/14/1998
Decision Date 11/03/1998
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
Predetermined Change
Control Plan Authorized		 No
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