FDA 510(k) Application Details - K073559

Device Classification Name Cannula, Catheter

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510(K) Number K073559
Device Name Cannula, Catheter
Applicant EDWARDS LIFESCIENCES RESEARCH MEDICAL
6864 SOUTH 300 WEST
MIDVALE, UT 84047 US
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Contact JOHN W NICHOLSON
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Regulation Number 870.1300

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Classification Product Code DQR
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Date Received 12/19/2007
Decision Date 01/31/2008
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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