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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 K203767
Device Name Pristine Long-Term Hemodialysis Catheter
Applicant
C B Bard, Inc
1625 W Third Street
Tempe,  AZ  85281
Applicant Contact Arieona Boyle
Correspondent
C B Bard, Inc
1625 W Third Street
Tempe,  AZ  85281
Correspondent Contact Arieona Boyle
Regulation Number876.5540
Classification Product Code
MSD  
Date Received12/23/2020
Decision Date 04/02/2021
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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