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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 K102084
Device Name STIMPOD NMS450 NERVE STIMULATOR
Applicant
XAVANT TECHNOLOGY (PTY), LTD.
169 GARSFONTEIN ROAD
ASHLEA GARDENS
PRETORIA, GAUTENG,  ZA 0081
Applicant Contact B ROTHMAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Regulation Number868.2775
Classification Product Code
BXN  
Date Received07/26/2010
Decision Date 12/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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