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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 K863979
Device Name MICROSCREEN I HEARING TESTER
Applicant
MICROSCREEN
1634 WEST WILLOW
PHOENIX,  AZ  85029
Applicant Contact JOANN M FELTER
Correspondent
MICROSCREEN
1634 WEST WILLOW
PHOENIX,  AZ  85029
Correspondent Contact JOANN M FELTER
Regulation Number874.1050
Classification Product Code
EWO  
Date Received10/14/1986
Decision Date 11/18/1986
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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