FDA 510(k) Application Details - K060092

Device Classification Name

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510(K) Number K060092
Device Name QUICKCAT EXTRACTION CATHETER
Applicant KENSEY NASH CORP.
735 PENNSYLVANIA AVE.
EXTON, PA 19341 US
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Contact DEBORAH L JACKSON
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Regulation Number

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Classification Product Code QEZ
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Date Received 01/12/2006
Decision Date 03/09/2006
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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