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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 K092089
Device Name CLARUJUST
Applicant
AUDIGENCE, INC.
1050 W. NASA BLVD.
SUITE 154
MELBOURNE,  FL  32901
Applicant Contact CRAIG PAGAN
Correspondent
AUDIGENCE, INC.
1050 W. NASA BLVD.
SUITE 154
MELBOURNE,  FL  32901
Correspondent Contact CRAIG PAGAN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/09/2009
Decision Date 03/10/2010
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
Predetermined Change
Control Plan Authorized		 No
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