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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 K983351
Device Name ILO292 DP ECHOPORT PLUS OAE SYSTEM
Applicant
OTODYNAMICS, LTD.
P.O. BOX 4341
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
OTODYNAMICS, LTD.
P.O. BOX 4341
CROFTON,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number874.1050
Classification Product Code
EWO  
Date Received09/23/1998
Decision Date 12/11/1998
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
Predetermined Change
Control Plan Authorized		 No
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