The following data is part of a premarket notification filed by Jiangsu Shenli Medical Production Co., Ltd with the FDA for Sterile Hypodermic Needle For Single Use.
| Device ID | K180259 |
| 510k Number | K180259 |
| Device Name: | Sterile Hypodermic Needle For Single Use |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Jiangsu Shenli Medical Production Co., Ltd No 20, Changzheng Road, Zhenglu Changzhou City, CN 213111 |
| Contact | Tina Cai |
| Correspondent | Charles Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-30 |
| Decision Date | 2018-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06935550811018 | K180259 | 000 |
| 06935550811025 | K180259 | 000 |