FDA 510(k) Application Details - K002677

Device Classification Name Stimulator, Nerve, Ac-Powered

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510(K) Number K002677
Device Name Stimulator, Nerve, Ac-Powered
Applicant NUVASIVE, INC.
10065 OLD GROVE RD.
SAN DIEGO, CA 92131 US
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Contact R. STEPHEN REITZLER
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Regulation Number 868.2775

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Classification Product Code BXM
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Date Received 08/28/2000
Decision Date 11/13/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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