FDA 510(k) Application Details - K071300

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K071300
Device Name Probe, Radiofrequency Lesion
Applicant SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact KATHY REDDIG
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 05/09/2007
Decision Date 07/20/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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