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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 K213049
Device Name STIMPOD NMS450 Nerve Stimulator
Applicant
Xavant Technology (Pty) Ltd
Unit 102 Tannery Industrial Park, 309 Derdepoort Road
Silverton
Pretoria,  ZA 0184
Applicant Contact Roche Janse van Rensburg
Correspondent
Xavant Technology (Pty) Ltd
Unit 102 Tannery Industrial Park, 309 Derdepoort Road
Silverton
Pretoria,  ZA 0184
Correspondent Contact Roche Janse van Rensburg
Regulation Number868.2775
Classification Product Code
BXN  
Date Received09/22/2021
Decision Date 10/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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