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FDA 510(k) Application Details - K133796
Device Classification Name
Catheter, Hemodialysis, Implanted
More FDA Info for this Device
510(K) Number
K133796
Device Name
Catheter, Hemodialysis, Implanted
Applicant
MARVAO MEDICAL DEVICES, LTD.
368 WEST MAIN STREET
SUITE 7
NORTHBOROUGH, MA 01532 US
Other 510(k) Applications for this Company
Contact
CHRISTINE NICHOLS, RAC
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
12/13/2013
Decision Date
01/31/2014
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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