CAREFINE PEN NEEDLE

Needle, Hypodermic, Single Lumen

FACET TECHNOLOGIES

The following data is part of a premarket notification filed by Facet Technologies with the FDA for Carefine Pen Needle.

Pre-market Notification Details

Device IDK133100
510k NumberK133100
Device Name:CAREFINE PEN NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant FACET TECHNOLOGIES 112 TOWN PARK DR. SUITE 300 Kennesaw,  GA  30144
ContactMary Ann Kinard
CorrespondentMary Ann Kinard
FACET TECHNOLOGIES 112 TOWN PARK DR. SUITE 300 Kennesaw,  GA  30144
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-30
Decision Date2014-01-23
Summary:summary

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