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FDA 510(k) Application Details - K061443
Device Classification Name
Stimulator, Auditory, Evoked Response
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510(K) Number
K061443
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
05/24/2006
Decision Date
06/23/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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