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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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More FDA Info for this Product Code
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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