Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G And 30G

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Owen Mumford Ltd

The following data is part of a premarket notification filed by Owen Mumford Ltd with the FDA for Unistik Touch Single-use Safety Lancets - 16g, 21g, 23g, 28g And 30g.

Pre-market Notification Details

Device IDK222111
510k NumberK222111
Device Name:Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G And 30G
ClassificationSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Applicant Owen Mumford Ltd Brook Hill Woodstock,  GB OX20 1TU
ContactDarren Mansell
CorrespondentDarren Mansell
Owen Mumford Ltd Brook Hill Woodstock,  GB OX20 1TU
Product CodeFMK  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-18
Decision Date2022-09-07

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