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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 K232781
Device Name Safety Sliding Blood Collection Set
Applicant
Jiangsu Caina Medical Co., Ltd.
No.23, Huanxi Road, Zhutang Town
Jiangyin,  CN 214415
Applicant Contact Camel Zhou
Correspondent
Jiangsu Caina Medical Co., Ltd.
No.23, Huanxi Road, Zhutang Town
Jiangyin,  CN 214415
Correspondent Contact Camel Zhou
Regulation Number862.1675
Classification Product Code
JKA  
Date Received09/11/2023
Decision Date 03/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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