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FDA 510(k) Application Details - K110973
Device Classification Name
Masker, Tinnitus
More FDA Info for this Device
510(K) Number
K110973
Device Name
Masker, Tinnitus
Applicant
WIDEX USA
2300 CABOT DRIVE, SUITE 415
LISLE, IL 60532 US
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Contact
FRANCIS KUK
Other 510(k) Applications for this Contact
Regulation Number
874.3400
More FDA Info for this Regulation Number
Classification Product Code
KLW
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More FDA Info for this Product Code
Date Received
04/06/2011
Decision Date
05/05/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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