FDA 510(k) Application Details - K073162

Device Classification Name Wire, Guide, Catheter

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510(K) Number K073162
Device Name Wire, Guide, Catheter
Applicant KENSEY NASH CORPORATION
735 PENNSYLVANIA DRIVE
EXTON, PA 19341 US
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Contact ROBIN FATZINGER
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 11/09/2007
Decision Date 02/08/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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