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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 K981125
Device Name MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
Applicant
MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Applicant Contact JEANNE M CUSH
Correspondent
MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE,  PA  19438
Correspondent Contact JEANNE M CUSH
Regulation Number876.5540
Classification Product Code
MSD  
Date Received03/27/1998
Decision Date 02/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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