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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 K210745
Device Name Heel Incision Safety Lancet
Applicant
SteriLance Medical (Suzhou), Inc.
#168 Putuoshan Rd.
New District
Suzhou,  CN 215153
Applicant Contact Yuan Jie
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Square, Nanshan
District
Shenzhen,  CN 518100
Correspondent Contact Joyce Yang
Regulation Number878.4850
Classification Product Code
FMK  
Date Received03/12/2021
Decision Date 08/26/2021
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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