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FDA 510(k) Application Details - K063431
Device Classification Name
Catheter, Hemodialysis, Implanted
More FDA Info for this Device
510(K) Number
K063431
Device Name
Catheter, Hemodialysis, Implanted
Applicant
SPIRE BIOMEDICAL INC
ONE PATRIOTS PARK
BEDFORD, MA 01730 US
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Contact
SHEKHAR D NIMKAR
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
11/13/2006
Decision Date
01/29/2007
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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