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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 K222055
Device Name Disposable Sterile Lancet
Applicant
Tianjin Rilifine Medical Device Co., Ltd.
No 32, Jingguan Rd., Yixingbu, Beichen District
Tianjin,  CN 300402
Applicant Contact Qiusheng Jiang
Correspondent
Tianjin Rilifine Medical Device Co., Ltd.
No 32, Jingguan Rd., Yixingbu, Beichen District
Tianjin,  CN 300402
Correspondent Contact Qiusheng Jiang
Regulation Number878.4850
Classification Product Code
FMK  
Date Received07/12/2022
Decision Date 11/15/2022
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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