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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 K222168
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
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 Received07/21/2022
Decision Date 11/03/2022
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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