FDA 510(k) Application Details - K093494

Device Classification Name Tracking, Soft Tissue, Intraoperative

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510(K) Number K093494
Device Name Tracking, Soft Tissue, Intraoperative
Applicant PATHFINDER THERAPEUTICS, INC.
2969 ARMORY DRIVE
SUITE 100A
NASHVILLE, TN 37204 US
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Contact CRAIG HENDERSON
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Regulation Number 882.4560

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Classification Product Code OEW
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Date Received 11/10/2009
Decision Date 03/30/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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