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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 -4233
Applicant Contact KATHLEEN A KELLER
Correspondent
MICRO AUDIOMETRICS CORP.
3749-B S. NOVA RD.
PORT ORANGE,  FL  32129 -4233
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
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