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FDA 510(k) Application Details - K022644
Device Classification Name
Kit, Repair, Catheter, Hemodialysis
More FDA Info for this Device
510(K) Number
K022644
Device Name
Kit, Repair, Catheter, Hemodialysis
Applicant
SPIRE BIOMEDICAL, INC.
ONE PATRIOTS PARK
BEDFORD, MA 01730-2396 US
Other 510(k) Applications for this Company
Contact
DONALD FICKETT
Other 510(k) Applications for this Contact
Regulation Number
876.5540
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Classification Product Code
NFK
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More FDA Info for this Product Code
Date Received
08/08/2002
Decision Date
11/06/2002
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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