MINI GHOST, MODEL: 507

Catheter, Percutaneous

NUMED, INC.

The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Mini Ghost, Model: 507.

Pre-market Notification Details

Device IDK082524
510k NumberK082524
Device Name:MINI GHOST, MODEL: 507
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 Received2008-09-02
Decision Date2008-09-26
Summary:summary

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