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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K231124
Device Name Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
Applicant
Owen Mumford, Ltd.
Brook Hill
Woodstock,  GB ox20 1tu
Applicant Contact Darren Mansell
Correspondent
Owen Mumford, Ltd.
Brook Hill
Woodstock,  GB ox20 1tu
Correspondent Contact Darren Mansell
Regulation Number878.4850
Classification Product Code
FMK  
Date Received04/20/2023
Decision Date 06/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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