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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 K973320
Device Name ARTICULATE FITTING SYSTEM
Applicant
DECIBEL INSTRUMENTS, INC.
9223 ILONA LN.
HOUSTON,  TX  77025 -4218
Applicant Contact LISA JONES
Correspondent
DECIBEL INSTRUMENTS, INC.
9223 ILONA LN.
HOUSTON,  TX  77025 -4218
Correspondent Contact LISA JONES
Regulation Number874.1050
Classification Product Code
EWO  
Date Received09/03/1997
Decision Date 11/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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