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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve
510(k) Number K040543
Device Name NUVASIVE NEUROVISION JJB SYSTEM
Applicant
NUVASIVE, INC.
10065 OLD GROVE RD.
SAN DIEGO,  CA  92131
Applicant Contact LAETITIA BERNARD
Correspondent
NUVASIVE, INC.
10065 OLD GROVE RD.
SAN DIEGO,  CA  92131
Correspondent Contact LAETITIA BERNARD
Regulation Number874.1820
Classification Product Code
ETN  
Subsequent Product Code
INK  
Date Received03/02/2004
Decision Date 04/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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