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FDA 510(k) Application Details - K060288
Device Classification Name
Catheter, Hemodialysis, Implanted
More FDA Info for this Device
510(K) Number
K060288
Device Name
Catheter, Hemodialysis, Implanted
Applicant
SPIRE BIOMEDICAL, INC.
ONE PATRIOTS PARK
BEDFORD, MA 01730-2396 US
Other 510(k) Applications for this Company
Contact
Ray Kelly
Other 510(k) Applications for this Contact
Regulation Number
876.5540
More FDA Info for this Regulation Number
Classification Product Code
MSD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/06/2006
Decision Date
09/01/2006
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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