NUMED Z-MED PTV CATHERERS

Catheter, Percutaneous

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Z-med Ptv Catherers.

Pre-market Notification Details

Device IDK003643
510k NumberK003643
Device Name:NUMED Z-MED PTV CATHERERS
ClassificationCatheter, Percutaneous
Applicant NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
ContactNichelle Laflesh
CorrespondentNichelle Laflesh
NUMED, INC. 2880 MAIN ST. Hopkinton,  NY  12965
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-27
Decision Date2000-12-27

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