The following data is part of a premarket notification filed by Jiangyin Caina Technology Co., Ltd. with the FDA for Enfit Enteral Syringe.
| Device ID | K161979 |
| 510k Number | K161979 |
| Device Name: | ENFit Enteral Syringe |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | JIANGYIN CAINA TECHNOLOGY CO., LTD. NO.2, TAIFU ROAD, HUASHI TOWN Jiangyin, CN 214421 |
| Contact | Jun Lu |
| 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 | 2016-07-18 |
| Decision Date | 2017-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850801006398 | K161979 | 000 |
| 20850801006381 | K161979 | 000 |
| 20888277727301 | K161979 | 000 |
| 20888277727295 | K161979 | 000 |
| 20888277727288 | K161979 | 000 |
| 20888277727271 | K161979 | 000 |
| 20888277727257 | K161979 | 000 |
| 20888277727240 | K161979 | 000 |
| 20888277727264 | K161979 | 000 |