FDA 510(k) Application Details - K003920

Device Classification Name Catheter, Percutaneous

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510(K) Number K003920
Device Name Catheter, Percutaneous
Applicant CORDIS CORP.
7 POWDER HORN DR.
WARREN, NJ 07059 US
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Contact CHARLES (CHUCK) J RYAN
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Regulation Number 870.1250

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Classification Product Code DQY
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Date Received 12/19/2000
Decision Date 06/15/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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