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FDA 510(k) Application Details - K110286
Device Classification Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
874.3310
More FDA Info for this Regulation Number
Classification Product Code
ETW
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More FDA Info for this Product Code
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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