Unifine SafeControl 5mm X 30G, Unifine SafeControl 8mm X 30G

Needle, Hypodermic, Single Lumen

Owen Mumford Ltd

The following data is part of a premarket notification filed by Owen Mumford Ltd with the FDA for Unifine Safecontrol 5mm X 30g, Unifine Safecontrol 8mm X 30g.

Pre-market Notification Details

Device IDK173881
510k NumberK173881
Device Name:Unifine SafeControl 5mm X 30G, Unifine SafeControl 8mm X 30G
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Owen Mumford Ltd Brook Hill Woodstock,  GB Ox20 1tu
ContactDarren Mansell
CorrespondentPatty Cronan
Owen Mumford USA Inc 1755 West Oak Commons CT Marietta,  CA  30062
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-21
Decision Date2018-07-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00384707955000 K173881 000
00384707935026 K173881 000
00384700935238 K173881 000

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