The following data is part of a premarket notification filed by U & U Medical Technology Co., Ltd with the FDA for U & U Intravascular Administration Set.
| Device ID | K151151 |
| 510k Number | K151151 |
| Device Name: | U & U Intravascular Administration Set |
| Classification | Set, Administration, Intravascular |
| Applicant | U & U Medical Technology Co., Ltd Dongzhou Village, Hengshanqiao Changzhou, CN 213119 |
| Contact | Xuebo Wang |
| Correspondent | Xuebo Wang U & U Medical Technology Co., Ltd Dongzhou Village, Hengshanqiao Changzhou, CN 213119 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-30 |
| Decision Date | 2015-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10369771001263 | K151151 | 000 |
| 30369771001250 | K151151 | 000 |
| 30369771000215 | K151151 | 000 |
| 10850014433137 | K151151 | 000 |