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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 K173881
Device Name Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G
Applicant
Owen Mumford, Ltd.
Brook Hill
Woodstock,  GB ox20 1tu
Applicant Contact Darren Mansell
Correspondent
Owen Mumford USA, Inc.
1755 W. Oak Commons Ct.
Marietta,  CA  30062
Correspondent Contact Patty Cronan
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/21/2017
Decision Date 07/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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