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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Use Blood Lancet For Single Patient Use Only
510(k) Number K221613
Device Name Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
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 Number878.4850
Classification Product Code
QRL  
Subsequent Product Code
QRK  
Date Received06/03/2022
Decision Date 10/03/2022
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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