FDA 510(k) Application Details - K032196

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K032196
Device Name Probe, Radiofrequency Lesion
Applicant NEW BUSINESS DEVELOPMENT, LLC
605 INDUSTRIAL COURT
WOODSTOCK, GA 30189 US
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Contact TIMOTHY B LUSBY
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 07/18/2003
Decision Date 10/09/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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