FDA 510(k) Application Details - K132694

Device Classification Name

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510(K) Number K132694
Device Name NUVASIVE NVM5 SYSTEM
Applicant NUVASIVE, INCORPORATED
7475 LUSK BOULEVARD
SAN DIEGO, CA 92121 US
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Contact Sheila Bruschi
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Regulation Number

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Classification Product Code PDQ
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Date Received 08/29/2013
Decision Date 05/16/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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