FDA 510(k) Applications Submitted by Darren Mansell
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210399 |
02/10/2021 |
Unifine SafeControl |
Owen Mumford Ltd |
| K221126 |
04/18/2022 |
Unistik« 3, sterile single-use safety lancets; Unistik« 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets |
Owen Mumford Ltd |
| K231124 |
04/20/2023 |
Unistik« 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) |
Owen Mumford Ltd |
| K221613 |
06/03/2022 |
Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets |
Owen Mumford Ltd |
| K222111 |
07/18/2022 |
Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G |
Owen Mumford Ltd |
| K222168 |
07/21/2022 |
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 |
Owen Mumford Ltd |
| K222303 |
08/01/2022 |
Unistik« Pro |
Owen Mumford Ltd |
| K122837 |
09/17/2012 |
AUTOJECT 2 FOR GLASSY SYRINGE |
OWEN MUMFORD, LTD. |
| K173881 |
12/21/2017 |
Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G |
Owen Mumford Ltd |
| K223854 |
12/23/2022 |
Unistik« ShieldLock, Unistik VacuFlip |
Owen Mumford Ltd |
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