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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 K812529
Device Name EARSCAN
Applicant
Micro Audiometrics Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Micro Audiometrics Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.1050
Classification Product Code
EWO  
Date Received09/02/1981
Decision Date 10/14/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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