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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 K883505
Device Name BIOMETER AUDIOMETER
Applicant
Micro Audiometrics Corp.
3749-B S. Nova Rd.
Port Orange,  FL  32129
Applicant Contact KATHLEEN A KELLER
Correspondent
Micro Audiometrics Corp.
3749-B S. Nova Rd.
Port Orange,  FL  32129
Correspondent Contact KATHLEEN A KELLER
Regulation Number874.1050
Classification Product Code
EWO  
Date Received08/17/1988
Decision Date 08/21/1989
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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