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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 K032712
Device Name VAXCEL PLUS CHRONIC DIALYSIS CATHETER
Applicant
Boston Scientific Corp
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact NICHOLAS CONDAKES
Correspondent
Boston Scientific Corp
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact NICHOLAS CONDAKES
Regulation Number876.5540
Classification Product Code
MSD  
Date Received09/02/2003
Decision Date 10/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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