FDA 510(k) Application Details - K050084

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K050084
Device Name Probe, Radiofrequency Lesion
Applicant COSMAN MEDICAL, INC.
76 CAMBRIDGE ST.
BURLINGTON, MA 01803-4140 US
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Contact MICHAEL ARNOLD
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 01/13/2005
Decision Date 03/17/2005
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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