FDA 510(k) Application Details - K023504

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K023504
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402-0489 US
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Contact KAREN BRADBURN
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 10/18/2002
Decision Date 11/13/2002
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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