FDA 510(k) Application Details - K042034

Device Classification Name Light, Surgical, Fiberoptic

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510(K) Number K042034
Device Name Light, Surgical, Fiberoptic
Applicant NUVASIVE, INC.
10065 OLD GROVE RD.
SAN DIEGO, CA 92131 US
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Contact LAETITIA COUSIN
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Regulation Number 878.4580

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Classification Product Code FST
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Date Received 07/29/2004
Decision Date 10/26/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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