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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems
510(k) Number K041853
Device Name OTOGRAM
Applicant
Tympany, Inc.
P.O. Box 7007
Deer Field,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Tympany, Inc.
P.O. Box 7007
Deer Field,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number874.3310
Classification Product Code
ETW  
Date Received07/08/2004
Decision Date 09/03/2004
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
Predetermined Change
Control Plan Authorized		 No
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