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FDA 510(k) Application Details - K063355
Device Classification Name
Catheter, Hemodialysis, Non-Implanted
More FDA Info for this Device
510(K) Number
K063355
Device Name
Catheter, Hemodialysis, Non-Implanted
Applicant
NOVOSCI CORP.
2828 NORTH CRESCENT RIDGE DR.
THE WOODLANDS, TX 77381-3902 US
Other 510(k) Applications for this Company
Contact
DAVID MAKANANI
Other 510(k) Applications for this Contact
Regulation Number
876.5540
More FDA Info for this Regulation Number
Classification Product Code
MPB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/07/2006
Decision Date
07/27/2007
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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