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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 K221175
Device Name Multi-Lancet Device 2, ReliOn Premier Lancing Device
Applicant
Arkray, Inc.
Yousuien-Nai, 59 Gansuin-Cho
Kamigyo-Ku
Kyoto,  JP 602-0008
Applicant Contact Shinjiro Sekimoto
Correspondent
Arkray Factory USA, Inc.
5182 W. 76th St.
Edina,  MN  55439
Correspondent Contact Joe Dempsey
Regulation Number878.4850
Classification Product Code
QRL  
Date Received04/25/2022
Decision Date 10/17/2022
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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