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FDA 510(k) Application Details - K974774
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K974774
Device Name
Catheter, Intravascular, Diagnostic
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON, IN 47402 US
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APRIL LAVENDER
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Regulation Number
870.1200
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Classification Product Code
DQO
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Date Received
12/22/1997
Decision Date
10/16/1998
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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