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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 K110118
Device Name STIMTRODE SINGLE USE NERVE STIMULATOR
Applicant
XAVANT TECHNOLOGY (PTY), LTD.
169 GARSFONTEIN ROAD
ASHLEA GARDENS
PRETORIA, GAUTENG,  ZA 0081
Applicant Contact BRIAN ROTHMAN
Correspondent
XAVANT TECHNOLOGY (PTY), LTD.
169 GARSFONTEIN ROAD
ASHLEA GARDENS
PRETORIA, GAUTENG,  ZA 0081
Correspondent Contact BRIAN ROTHMAN
Regulation Number868.2775
Classification Product Code
BXN  
Date Received01/18/2011
Decision Date 02/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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