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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K222408
Device Name Disposable Safety Lancet
Applicant
Beijing Ruicheng Medical Supplies Co., Ltd.
No.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, Building #15, XiYueHui, No.5, YiHe North Rd.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4850
Classification Product Code
FMK  
Date Received08/10/2022
Decision Date 11/29/2022
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
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