DUO FLOW CATHETER-MC 54

Accessories, A-v Shunt

MEDICAL COMPONENTS, INC.

The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Duo Flow Catheter-mc 54.

Pre-market Notification Details

Device IDK842416
510k NumberK842416
Device Name:DUO FLOW CATHETER-MC 54
ClassificationAccessories, A-v Shunt
Applicant MEDICAL COMPONENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKNZ  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-20
Decision Date1984-07-26

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