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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 K890864
Device Name HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.
Applicant
Rastronics USA, Inc.
768 Foster Ave.
Bensenville,  IL  60106
Applicant Contact KURT TREDE
Correspondent
Rastronics USA, Inc.
768 Foster Ave.
Bensenville,  IL  60106
Correspondent Contact KURT TREDE
Regulation Number874.1090
Classification Product Code
ETY  
Date Received02/21/1989
Decision Date 06/21/1989
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
Predetermined Change
Control Plan Authorized		 No
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