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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K223854
Device Name Unistik® ShieldLock, Unistik VacuFlip
Applicant
Owen Mumford, Ltd.
Owen Mumford, Brook Hill, Woodstock
Woodstock,  GB OX20 ITU
Applicant Contact Darren Mansell
Correspondent
Owen Mumford USA, Inc.
1755 W. Oak Commons Ct.
Marietta,  GA  30062
Correspondent Contact Patty Cronan
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FMI  
Date Received12/23/2022
Decision Date 06/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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