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FDA 510(k) Application Details - K042034
Device Classification Name
Light, Surgical, Fiberoptic
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.4580
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Classification Product Code
FST
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More FDA Info for this Product Code
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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