The following data is part of a premarket notification filed by Jiangsu Kangbao Medical Experiment Co., Ltd with the FDA for Enteral Feeding Syringes With Enfit Connectors.
| Device ID | K182649 |
| 510k Number | K182649 |
| Device Name: | Enteral Feeding Syringes With Enfit Connectors |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | Jiangsu Kangbao Medical Experiment Co., Ltd 78#, North Suzhong Road, Baoying Yangzhou, CN 225800 |
| Contact | Qian Li |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2018-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850016172372 | K182649 | 000 |
| 00850016172099 | K182649 | 000 |
| 00850016172112 | K182649 | 000 |
| 00850016172020 | K182649 | 000 |
| 00850016172044 | K182649 | 000 |
| 00850016172068 | K182649 | 000 |
| 00850016172075 | K182649 | 000 |
| 00850016172181 | K182649 | 000 |
| 00850016172228 | K182649 | 000 |
| 00850016172341 | K182649 | 000 |
| 00815991025006 | K182649 | 000 |