MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6

Catheter, Hemodialysis, Implanted

MEDICAL COMPONENTS, INC.

The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp Tesio Catheter, Models Mbr-6, Mbl-6, Mbs-6.

Pre-market Notification Details

Device IDK981125
510k NumberK981125
Device Name:MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
ClassificationCatheter, Hemodialysis, Implanted
Applicant MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville,  PA  19438
ContactJeanne M Cush
CorrespondentJeanne M Cush
MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville,  PA  19438
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-27
Decision Date1999-02-26

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