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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 K070312
Device Name EARCHECK ACOUSTIC REFLECTOMETER
Applicant
Innovia Medical, LLC
13 Red Fox Lane
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Innovia Medical, LLC
13 Red Fox Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number874.1090
Classification Product Code
ETY  
Date Received02/01/2007
Decision Date 03/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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