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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 K200627
Device Name GlidePath 10F Long-Term Dialysis Catheter
Applicant
C.R. Bard, Inc.
1625 W Third St.
Tempe,  AZ  85281
Applicant Contact Joan Bergstrom
Correspondent
C.R. Bard, Inc.
1625 W Third St.
Tempe,  AZ  85281
Correspondent Contact Joan Bergstrom
Regulation Number876.5540
Classification Product Code
MSD  
Date Received03/10/2020
Decision Date 06/22/2020
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
Predetermined Change
Control Plan Authorized		 No
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