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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 K200027
Device Name Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
Applicant
Jiangsu Caina Medical Co.,Ltd
# 23, Huanxi Rd. Zhutang Town
Jiangyin,  CN 214415
Applicant Contact Jianwei Pan
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number862.1675
Classification Product Code
JKA  
Subsequent Product Code
FMI  
Date Received01/06/2020
Decision Date 09/09/2020
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
Predetermined Change
Control Plan Authorized		 No
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