FDA 510(k) Application Details - K090608

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K090608
Device Name Probe, Radiofrequency Lesion
Applicant MINTA MEDICAL LIMITED
CADDICK ROAD
KNOWSLEY MERSEYSIDE L34 9HP GB
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Contact ANDREW EDWARDS
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 03/06/2009
Decision Date 06/14/2010
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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