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FDA 510(k) Application Details - K990726
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K990726
Device Name
Catheter, Percutaneous
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON, IN 47402 US
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Contact
APRIL LAVENDER
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Regulation Number
870.1250
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Classification Product Code
DQY
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Date Received
03/05/1999
Decision Date
04/02/1999
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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