The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Pre-filled Syringe With Saline.
| Device ID | K220060 |
| 510k Number | K220060 |
| Device Name: | Pre-filled Syringe With Saline |
| Classification | Saline, Vascular Access Flush |
| Applicant | Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Rd, Zhutang Town Jiangyin, CN 214415 |
| Contact | Jianwei Pan |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O Box 120-119 Shanghai, CN 200120 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-10 |
| Decision Date | 2022-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00369771003437 | K220060 | 000 |
| 20612479273157 | K220060 | 000 |
| 20612479273188 | K220060 | 000 |
| 10386120013098 | K220060 | 000 |
| 00840117334489 | K220060 | 000 |
| 08401173345264 | K220060 | 000 |
| 10850049248065 | K220060 | 000 |
| 00811220035143 | K220060 | 000 |
| 00811220035174 | K220060 | 000 |
| 00811220035099 | K220060 | 000 |
| 00811220035112 | K220060 | 000 |
| 00840117334533 | K220060 | 000 |