FDA 510(k) Application Details - K920824

Device Classification Name Wire, Guide, Catheter

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510(K) Number K920824
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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Date Received 02/24/1992
Decision Date 10/16/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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