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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 K980505
Device Name HORTMANN AMDIS-OAE OAE ANALYZER
Applicant
HORTMANN AG
P.O. BOX 1119
DRIPPING SPRINGS,  TX  78620
Applicant Contact BRADFORD MELANCON
Correspondent
HORTMANN AG
P.O. BOX 1119
DRIPPING SPRINGS,  TX  78620
Correspondent Contact BRADFORD MELANCON
Regulation Number874.1050
Classification Product Code
EWO  
Date Received02/09/1998
Decision Date 04/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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