The following data is part of a premarket notification filed by Anhui Tiankang Medical Technology Co.,ltd with the FDA for Tk Sterile Hypodermic Needle.
| Device ID | K191643 |
| 510k Number | K191643 |
| Device Name: | TK Sterile Hypodermic Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Anhui Tiankang Medical Technology CO.,Ltd NO.228 Weiyi Road, Economic Development Zone Tianchang, CN 239300 |
| Contact | Bai Baodong |
| Correspondent | Bai Baodong Anhui Tiankang Medical Technology CO.,Ltd NO.228 Weiyi Road, Economic Development Zone Tianchang, CN 239300 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-19 |
| Decision Date | 2019-12-19 |