FDA 510(k) Application Details - K082012

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K082012
Device Name Probe, Radiofrequency Lesion
Applicant COSMAN MEDICAL, INC.
76 CAMBRIDGE ST.
BURLINGTON, MA 01803-4140 US
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Contact LOUIS FALCONE
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 07/15/2008
Decision Date 10/14/2008
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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