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FDA 510(k) Application Details - K080955
Device Classification Name
Masker, Tinnitus
More FDA Info for this Device
510(K) Number
K080955
Device Name
Masker, Tinnitus
Applicant
WIDEX HEARING AID CO., INC.
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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/03/2008
Decision Date
06/27/2008
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
N
Expedited Review
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