Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie And Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term And Toddler

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 Tinytouch Sterile Single-use Heel Incision Safety Lancets - Preemie And Full-term, Unistik Heelstik Sterile Single-use Heel Incision Safety Lancets - Micropreemie, Preemie, Full-term And Toddler.

Pre-market Notification Details

Device IDK222168
510k NumberK222168
Device Name:Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie And Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term And Toddler
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 Received2022-07-21
Decision Date2022-11-03

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.