Eclipse DermaFlex Cannula

Needle, Hypodermic, Single Lumen

Eclipse MedCorp, LLC

The following data is part of a premarket notification filed by Eclipse Medcorp, Llc with the FDA for Eclipse Dermaflex Cannula.

Pre-market Notification Details

Device IDK200017
510k NumberK200017
Device Name:Eclipse DermaFlex Cannula
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Eclipse MedCorp, LLC 5916 Stone Creek Drive Suite#120 The Colony,  TX  75056
ContactJohn Tepper
CorrespondentJulie Summerville
Eclipse MedCorp, LLC 5916 Stone Creek Drive Suite#120 The Colony,  TX  75056
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-03
Decision Date2020-11-05

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