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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 K060885
Device Name MODEL MI 44 TYMPANOMETER
Applicant
MAICO-DIAGNOSTICS
7625 GOLDEN TRIANGLE DRIVE
EDEN PRAIRIE,  MN  55344
Applicant Contact DANIEL EGGAN
Correspondent
MAICO-DIAGNOSTICS
7625 GOLDEN TRIANGLE DRIVE
EDEN PRAIRIE,  MN  55344
Correspondent Contact DANIEL EGGAN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received03/31/2006
Decision Date 06/05/2006
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
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