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FDA 510(k) Application Details - K880722
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K880722
Device Name
Wire, Guide, Catheter
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON, IN US
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Contact
APRIL LAVENDER
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Regulation Number
870.1330
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Classification Product Code
DQX
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More FDA Info for this Product Code
Date Received
02/23/1988
Decision Date
08/19/1988
Decision
SE - Substantially Equivalent
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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