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FDA 510(k) Application Details - K061104
Device Classification Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
More FDA Info for this Device
510(K) Number
K061104
Device Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Applicant
GN OTOMETRICS A/S
DYBENDALSVAENGET 2
P.O. BOX 119
TAASTRUP DK-2630 DK
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Contact
PER PAPE THOMSEN
Other 510(k) Applications for this Contact
Regulation Number
874.3310
More FDA Info for this Regulation Number
Classification Product Code
ETW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/20/2006
Decision Date
05/03/2006
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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