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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, Ac-Powered
510(k) Number K002677
Device Name NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
Applicant
Nuvasive, Inc.
10065 Old Grove Rd.
San Diego,  CA  92131
Applicant Contact R. STEPHEN REITZLER
Correspondent
Nuvasive, Inc.
10065 Old Grove Rd.
San Diego,  CA  92131
Correspondent Contact R. STEPHEN REITZLER
Regulation Number868.2775
Classification Product Code
BXM  
Date Received08/28/2000
Decision Date 11/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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