510(k) K200027

Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter by Jiangsu Caina Medical Co.,Ltd — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2020
Date Received
January 6, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type