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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
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 W. Main St., Suite 7
Northborough,  MA  01532
Applicant Contact Marybeth Gamber
Correspondent
Marvao Medical Devices, Ltd.
368 W. Main St., Suite 7
Northborough,  MA  01532
Correspondent Contact Marybeth Gamber
Regulation Number876.5540
Classification Product Code
MSD  
Date Received07/02/2012
Decision Date 03/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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