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