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FDA 510(k) Application Details - K130346
Device Classification Name
Stimulator, Electrical, Evoked Response
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510(K) Number
K130346
Device Name
Stimulator, Electrical, Evoked Response
Applicant
NATUS NEUROLOGY INCORPORATED
1850 DEMING WAY
MIDDLETON, WI 53562-0000 US
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Contact
SHANE T SAWALL
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Regulation Number
882.1870
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Classification Product Code
GWF
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More FDA Info for this Product Code
Date Received
02/11/2013
Decision Date
05/02/2013
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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