FDA 510(k) Application Details - K051384

Device Classification Name Stimulator, Electrical, Evoked Response

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510(K) Number K051384
Device Name Stimulator, Electrical, Evoked Response
Applicant NUVASIVE, INC.
4545 TOWNE CENTRE COURT
SAN DIEGO, CA 92121 US
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Contact LAETITIA COUSIN
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Regulation Number 882.1870

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Classification Product Code GWF
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Date Received 05/27/2005
Decision Date 07/11/2005
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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