FDA 510(k) Application Details - K072092

Device Classification Name Stimulator, Nerve, Battery-Powered

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510(K) Number K072092
Device Name Stimulator, Nerve, Battery-Powered
Applicant XAVANT TECHNOLOGY (PTY), LTD.
181 SOUTPANSBERG RD.
RIETONDALE
PRETORIA 0084 ZA
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Contact ROCHE VAN RENSBURG
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Regulation Number 868.2775

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Classification Product Code BXN
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Date Received 07/30/2007
Decision Date 11/15/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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