FDA 510(k) Application Details - K062937

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K062937
Device Name Probe, Radiofrequency Lesion
Applicant BAYLIS MEDICAL CO., INC.
2580 MATHESON BLVD. E
MISSISSAUGA, ONTARIO L4W 4J1 CA
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Contact MEGHAL KHAKHAR
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 09/28/2006
Decision Date 01/08/2007
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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