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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 K000184
Device Name AUDIOSCREENER OAE
Applicant
Kedly, Inc.
920 S. Highway Dr.
St. Louis,  MO  63026
Applicant Contact RANDALL J KROHN
Correspondent
Kedly, Inc.
920 S. Highway Dr.
St. Louis,  MO  63026
Correspondent Contact RANDALL J KROHN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received01/20/2000
Decision Date 02/11/2000
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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