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FDA 510(k) Application Details - K162210
Device Classification Name
Tester, Auditory Impedance
More FDA Info for this Device
510(K) Number
K162210
Device Name
Tester, Auditory Impedance
Applicant
MAICO DIAGNOSTICS GMBH
SICKINGENSTR. 70-71
BERLIN 10553 DE
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Contact
UWE LEDWORUSKI
Other 510(k) Applications for this Contact
Regulation Number
874.1090
More FDA Info for this Regulation Number
Classification Product Code
ETY
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More FDA Info for this Product Code
Date Received
08/05/2016
Decision Date
11/16/2016
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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