The following data is part of a premarket notification filed by U&u Medical Technology Co., Ltd with the FDA for U&u Sterile Hypodermic Needle.
| Device ID | K132552 |
| 510k Number | K132552 |
| Device Name: | U&U STERILE HYPODERMIC NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | U&U MEDICAL TECHNOLOGY CO., LTD DONGZHOU VILLAGE, HENGSHANQIAO Changzhou, Jiangsu, CN 213119 |
| Contact | Xuebo Wang |
| Correspondent | Xuebo Wang U&U MEDICAL TECHNOLOGY CO., LTD DONGZHOU VILLAGE, HENGSHANQIAO Changzhou, Jiangsu, CN 213119 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-14 |
| Decision Date | 2013-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G002011070 | K132552 | 000 |