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FDA 510(k) Application Details - K040402
Device Classification Name
Catheter, Hemodialysis, Implanted
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510(K) Number
K040402
Device Name
Catheter, Hemodialysis, Implanted
Applicant
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY, NY 12804 US
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Contact
TERI JUCKETT
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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
02/17/2004
Decision Date
04/19/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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