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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 K222034
Device Name RightLance Blood Lancing System
Applicant
Beijing Ruicheng Medical Supplies Co., Ltd.
#13 Yanqi Ave., Yanqi Economic Development Zone,
Huairou District
Beijing,  CN 101400
Applicant Contact Yuechao Li
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4850
Classification Product Code
QRL  
Subsequent Product Code
QRK  
Date Received07/11/2022
Decision Date 09/07/2022
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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