FDA 510(k) Application Details - K113498

Device Classification Name Wire, Guide, Catheter

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510(K) Number K113498
Device Name Wire, Guide, Catheter
Applicant COEUR, INC.
100 PHYSICIANS WAY
SUITE 200
LEBANON, TN 37090 US
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Contact DEBRA F MANNING
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 11/25/2011
Decision Date 07/20/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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