The following data is part of a premarket notification filed by U&u Medical Technology Co.,ltd with the FDA for U&u Enteral Syringe.
| Device ID | K160855 |
| 510k Number | K160855 |
| Device Name: | U&U Enteral Syringe |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | U&U MEDICAL TECHNOLOGY CO.,LTD DONGZHOU VILLAGE, HENGYSHANQIAO Changzhou, CN 213119 |
| Contact | Black Wang |
| Correspondent | Black Wang U&U MEDICAL TECHNOLOGY CO.,LTD DONGZHOU VILLAGE, HENGYSHANQIAO Changzhou, CN 213119 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-28 |
| Decision Date | 2016-11-22 |
| Summary: | summary |