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FDA 510(k) Application Details - K092797
Device Classification Name
Kit, Repair, Catheter, Hemodialysis
More FDA Info for this Device
510(K) Number
K092797
Device Name
Kit, Repair, Catheter, Hemodialysis
Applicant
KENDALL
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
Other 510(k) Applications for this Company
Contact
Daniel Campion
Other 510(k) Applications for this Contact
Regulation Number
876.5540
More FDA Info for this Regulation Number
Classification Product Code
NFK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/11/2009
Decision Date
11/19/2009
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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