FDA 510(k) Application Details - K072864

Device Classification Name Stylet, Catheter

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510(K) Number K072864
Device Name Stylet, Catheter
Applicant ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 VALLEY VIEW CT.
SYLMAR, CA 91342 US
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Contact COLLEEN CANAN
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Regulation Number 870.1380

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Classification Product Code DRB
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Date Received 10/05/2007
Decision Date 03/13/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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