FDA 510(k) Application Details - K110286

Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems

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510(K) Number K110286
Device Name Calibrator, Hearing Aid / Earphone And Analysis Systems
Applicant GN OTOMETRICS A/S
125 COMMERCE DRIVE
SCHAUMBURG, IL 60173-5329 US
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Contact TOM RINIKER
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Regulation Number 874.3310

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Classification Product Code ETW
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Date Received 01/31/2011
Decision Date 04/28/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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