Unifine SafeControl

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.

Pre-market Notification Details

Device IDK210399
510k NumberK210399
Device Name:Unifine SafeControl
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Owen Mumford Ltd Brook Hill Woodstock,  GB Ox20 1tu
ContactDarren Mansell
CorrespondentDarren Mansell
Owen Mumford Ltd Brook Hill Woodstock,  GB Ox20 1tu
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-10
Decision Date2021-09-17

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