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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, Peripheral, Electric
510(k) Number K023342
Device Name NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG
Applicant
Hdc Corp.
628 Gibraltar Ct.
Milpitas,  CA  95035
Applicant Contact EARL SMART
Correspondent
Hdc Corp.
628 Gibraltar Ct.
Milpitas,  CA  95035
Correspondent Contact EARL SMART
Regulation Number868.2775
Classification Product Code
KOI  
Date Received10/07/2002
Decision Date 03/02/2004
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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