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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tester, auditory impedance
510(k) Number K883293
Device Name STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
Applicant
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Applicant Contact DAN REGAN
Correspondent
STORZ INSTRUMENT CO.
3365 TREE CT. INDUSTRIAL BLVD.
ST. LOUIS,  MO  63122 -6694
Correspondent Contact DAN REGAN
Regulation Number874.1090
Classification Product Code
ETY  
Date Received08/04/1988
Decision Date 06/09/1989
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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