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FDA 510(k) Application Details - K982333
Device Classification Name
Catheter, Hemodialysis, Implanted
More FDA Info for this Device
510(K) Number
K982333
Device Name
Catheter, Hemodialysis, Implanted
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
876.5540
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Classification Product Code
MSD
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More FDA Info for this Product Code
Date Received
07/02/1998
Decision Date
02/12/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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