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FDA 510(k) Application Details - K090528
Device Classification Name
Catheter, Hemodialysis, Implanted
More FDA Info for this Device
510(K) Number
K090528
Device Name
Catheter, Hemodialysis, Implanted
Applicant
C.R. BARD, INC.
605 N 5600 W
SALT LAKE CITY, UT 84116 US
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Contact
JI HYUN KIM
Other 510(k) Applications for this Contact
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
02/27/2009
Decision Date
05/28/2009
Decision
SESK - SUBST EQUIV - KIT
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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