CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT

Needle, Hypodermic, Single Lumen

FACET TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Facet Technologies, Llc with the FDA for Carefine Pen Needle Family Including Quintapoint And Superpoint.

Pre-market Notification Details

Device IDK141749
510k NumberK141749
Device Name:CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT
ClassificationNeedle, Hypodermic, Single Lumen
Applicant FACET TECHNOLOGIES, LLC 112 TOWN PARK DR. SUITE 300 Kennesaw,  GA  30144
ContactJennifer Register
CorrespondentJennifer Register
FACET TECHNOLOGIES, LLC 112 TOWN PARK DR. SUITE 300 Kennesaw,  GA  30144
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-30
Decision Date2014-07-29
Summary:summary

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