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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K213146
Device Name Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen
Applicant
Jiangsu Rongye Technology Co., Ltd.
Touqiao Town, Yangzhou City
Jiangsu,  CN 225109
Applicant Contact Tina Jiang
Correspondent
Jiangsu Rongye Technology Co., Ltd.
Touqiao Town, Yangzhou City
Jiangsu,  CN 225109
Correspondent Contact Tina Jiang
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FMI  
Date Received09/27/2021
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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