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510(k) Data Aggregation

K Number

Device Name

Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)

Manufacturer

Owen Mumford Ltd

Date Cleared

2023-06-27

(68 days)

Product Code

Regulation Number

Type

Panel

General and Plastic Surgery (SU)

Reference & Predicate Devices

N/A

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Device Name :

Unistik**®** 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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