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FDA 510(k) Application Details - K071821
Device Classification Name
Stimulator, Electrical, Evoked Response
More FDA Info for this Device
510(K) Number
K071821
Device Name
Stimulator, Electrical, Evoked Response
Applicant
TONICA ELEKTRONIK A/S
LUCERNEMARKEN 15
FARUM 3520 DK
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Contact
LISE TERKELSEN
Other 510(k) Applications for this Contact
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
07/03/2007
Decision Date
07/27/2007
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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