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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, Battery-Powered
510(k) Number K072092
Device Name XPOD/XMAP NERVE STIMULATOR
Applicant
XAVANT TECHNOLOGY (PTY), LTD.
181 SOUTPANSBERG RD.
RIETONDALE
PRETORIA,  ZA 0084
Applicant Contact ROCHE VAN RENSBURG
Correspondent
XAVANT TECHNOLOGY (PTY), LTD.
181 SOUTPANSBERG RD.
RIETONDALE
PRETORIA,  ZA 0084
Correspondent Contact ROCHE VAN RENSBURG
Regulation Number868.2775
Classification Product Code
BXN  
Date Received07/30/2007
Decision Date 11/15/2007
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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