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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 Without An Integral Sharps Injury Prevention Feature
510(k) Number K244031
Device Name Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
Applicant
SteriLance Medical (Suzhou), Inc.
#168 Putuoshan Rd., New District
Suzhou,  CN 215253
Applicant Contact Susan Sun
Correspondent
SteriLance Medical (Suzhou), Inc.
#168 Putuoshan Rd., New District
Suzhou,  CN 215253
Correspondent Contact Susan Sun
Regulation Number878.4850
Classification Product Code
QRK  
Date Received12/30/2024
Decision Date 02/26/2025
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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