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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K210399
Device Name Unifine SafeControl
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 Number880.5570
Classification Product Code
FMI  
Date Received02/10/2021
Decision Date 09/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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