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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, hemodialysis, implanted
510(K) Number K121933
Models NEXHD1552401, NEXHD1552801
Device Name NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)
Applicant
MARVAO MEDICAL DEVICES, LTD.
368 west main street
suite 7
northborough,  MA  01532
Contact marybeth gamber
Regulation Number876.5540
Classification Product Code
MSD  
Date Received07/02/2012
Decision Date 03/14/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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