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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
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