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FDA 510(k) Application Details - K090579
Device Classification Name
Stimulator, Auditory, Evoked Response
More FDA Info for this Device
510(K) Number
K090579
Device Name
Stimulator, Auditory, Evoked Response
Applicant
INTELLIGENT HEARING SYSTEMS
6860 S.W. 81ST ST.
MIAMI, FL 33143 US
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Contact
EDWARD MISKIEL
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Regulation Number
882.1900
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Classification Product Code
GWJ
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More FDA Info for this Product Code
Date Received
03/03/2009
Decision Date
07/07/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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