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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 K221778
Device Name Disposable Safety Lancets
Applicant
Suzhou Kyuan Medical Apparatus Co., Ltd.
Beiqiao Town, Suzhou City, P.R.China
Suzhou,  CN
Applicant Contact Shi Ye
Correspondent
Suzhou Kyuan Medical Apparatus Co., Ltd.
Beiqiao Town, Suzhou City, P.R.China
Suzhou,  CN
Correspondent Contact Shi Ye
Regulation Number878.4850
Classification Product Code
FMK  
Date Received06/21/2022
Decision Date 10/03/2022
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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