The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for 1ml Luer Slip Or Luer Lock Syringe, Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle.
| Device ID | K192551 |
| 510k Number | K192551 |
| Device Name: | 1ml Luer Slip Or Luer Lock Syringe, Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle |
| Classification | Syringe, Antistick |
| Applicant | Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214415 |
| Contact | Xinyan Ruan |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | MEG |
| Subsequent Product Code | FMF |
| Subsequent Product Code | FMI |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-17 |
| Decision Date | 2020-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16971564465165 | K192551 | 000 |
| 10850041572731 | K192551 | 000 |
| 10850041572748 | K192551 | 000 |
| 10850041572755 | K192551 | 000 |
| 10850041572762 | K192551 | 000 |
| 20193489099215 | K192551 | 000 |
| 16971564466025 | K192551 | 000 |
| 16971564465615 | K192551 | 000 |
| 16971564465264 | K192551 | 000 |
| 10850041572724 | K192551 | 000 |