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FDA 510(k) Application Details - K041914
Device Classification Name
Catheter, Hemodialysis, Implanted
More FDA Info for this Device
510(K) Number
K041914
Device Name
Catheter, Hemodialysis, Implanted
Applicant
KENDALL
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
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Contact
JIM WELSH
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
07/16/2004
Decision Date
09/27/2004
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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