The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Pump Alignment Syringe.
| Device ID | K220184 |
| 510k Number | K220184 |
| Device Name: | Pump Alignment Syringe |
| Classification | Syringe, Piston |
| Applicant | Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214415 |
| Contact | Jianwei Pan |
| Correspondent | Jianwei Pan Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214415 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-24 |
| Decision Date | 2022-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193489181685 | K220184 | 000 |
| 10850041572649 | K220184 | 000 |
| 10850041572625 | K220184 | 000 |
| 10850041572618 | K220184 | 000 |
| 10850041572052 | K220184 | 000 |
| 10850041572045 | K220184 | 000 |
| 10850060997249 | K220184 | 000 |
| 10850060997232 | K220184 | 000 |
| 10850060997225 | K220184 | 000 |
| 10850060997218 | K220184 | 000 |
| 10850060997201 | K220184 | 000 |
| 10850060997195 | K220184 | 000 |
| 10850060997188 | K220184 | 000 |
| 10850060997171 | K220184 | 000 |
| 10850041572557 | K220184 | 000 |
| 10850041572564 | K220184 | 000 |
| 10193489181678 | K220184 | 000 |
| 10193489181661 | K220184 | 000 |
| 10193489181654 | K220184 | 000 |
| 10193489181647 | K220184 | 000 |
| 10193489181630 | K220184 | 000 |
| 10850041572076 | K220184 | 000 |
| 10850041572069 | K220184 | 000 |
| 10850041572038 | K220184 | 000 |
| 00850041572017 | K220184 | 000 |
| 10850041572601 | K220184 | 000 |
| 10850041572595 | K220184 | 000 |
| 10850041572588 | K220184 | 000 |
| 00850041572574 | K220184 | 000 |
| 10850060997164 | K220184 | 000 |