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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 K971925
Device Name MEDCOMP BIO-FLEX CS CATHETER (CS100)
Applicant
MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Applicant Contact JEANNE CUSH
Correspondent
MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Correspondent Contact JEANNE CUSH
Regulation Number876.5540
Classification Product Code
MSD  
Date Received05/23/1997
Decision Date 02/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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