The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Single Use O-ring Gasket Syringe With Enfit Connector, Reusable O-ring Gasket Syringe With Enfit Connector.
| Device ID | K222155 |
| 510k Number | K222155 |
| Device Name: | Single Use O-ring Gasket Syringe With ENFit Connector, Reusable O-ring Gasket Syringe With ENFit Connector |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | Jiangsu Caina Medical Co., Ltd. No. 23, Huanxi Rd. Zhutang Town Jiangyin, CN 214415 |
| Contact | Jianwei Pan |
| Correspondent | Jianwei Pan Jiangsu Caina Medical Co., Ltd. No. 23, Huanxi Rd. Zhutang Town Jiangyin, CN 214415 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-20 |
| Decision Date | 2022-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40810096151207 | K222155 | 000 |
| 00810096151193 | K222155 | 000 |