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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 K093591
Device Name STIMPOD MODEL NMS-400 NERVE STIMULATOR
Applicant
Xavant Technology (Pty), Ltd.
169 Garsfontein Rd.
Ashlea Gardens
Pretoria, Gauteng,  ZA 0081
Applicant Contact BRIAN ROTHMAN
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number868.2775
Classification Product Code
BXN  
Date Received11/19/2009
Decision Date 12/03/2009
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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