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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 K233796
Device Name Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
Applicant
SteriLance Medical (Suzhou) Inc.
No.168 PuTuoShan Road
New District
Suzhou,  CN 215153
Applicant Contact Susan Sun
Correspondent
SteriLance Medical (Suzhou) Inc.
No.168 PuTuoShan Road
New District
Suzhou,  CN 215153
Correspondent Contact Susan Sun
Regulation Number878.4850
Classification Product Code
FMK  
Date Received11/29/2023
Decision Date 01/16/2024
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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