The following data is part of a premarket notification filed by U&u Medical Technology Co., Ltd with the FDA for U&u Insulin Syringe With/without Safety Retractable Device.
| Device ID | K152808 |
| 510k Number | K152808 |
| Device Name: | U&U Insulin Syringe With/without Safety Retractable Device |
| Classification | Syringe, Antistick |
| Applicant | U&U Medical Technology Co., Ltd Dongzhou Village, Hengshanqiao Changzhou, CN 213119 |
| Contact | Black Wang |
| Correspondent | Black Wang U&U Medical Technology Co., Ltd Dongzhou Village, Hengshanqiao Changzhou, CN 213119 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2016-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10370393311012 | K152808 | 000 |
| 10370393310015 | K152808 | 000 |
| 10370393302010 | K152808 | 000 |
| 00370393301016 | K152808 | 000 |
| 00370393300019 | K152808 | 000 |