FDA 510(k) Application Details - K131446

Device Classification Name Cannula, Catheter

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510(K) Number K131446
Device Name Cannula, Catheter
Applicant INTEGRA LIFESCIENCES CORPORATION
589 DAVIES DRIVE
YORK, PA 17402 US
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Contact STEPHANIE N SHEESLEY
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Regulation Number 870.1300

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Classification Product Code DQR
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Date Received 05/20/2013
Decision Date 10/28/2013
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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