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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Use Blood Lancet For Single Patient Use Only
510(k) Number K220387
Device Name Disposable Blood Lancets
Applicant
Suzhou Kyuan Medical Apparatus Co., Ltd.
Beiqiao Town
Suzhou,  CN
Applicant Contact Shi Ye
Correspondent
Suzhou Kyuan Medical Apparatus Co., Ltd.
Beiqiao Town
Suzhou,  CN
Correspondent Contact Shi Ye
Regulation Number878.4850
Classification Product Code
QRL  
Subsequent Product Code
QRK  
Date Received02/10/2022
Decision Date 08/17/2022
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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