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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, metal
510(k) Number K020853
Device Name NUVASIVE MESH
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 Number878.3300
Classification Product Code
EZX  
Date Received03/15/2002
Decision Date 06/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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