The following data is part of a premarket notification filed by Anhui Tiankang Medical Technology Co., Ltd. with the FDA for Disposabel Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle.
| Device ID | K220204 |
| 510k Number | K220204 |
| Device Name: | Disposabel Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle |
| Classification | Syringe, Piston |
| Applicant | Anhui Tiankang Medical Technology Co., Ltd. No.228,Weiyi Road, Economic Development Zone,Tianchang City, Anhui,China. Tianchang, CN 239300 |
| Contact | Zhang Yong |
| Correspondent | Zhang Yong Anhui Tiankang Medical Technology Co., Ltd. No.228,Weiyi Road, Economic Development Zone,Tianchang City, Anhui,China. Tianchang, CN 239300 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-25 |
| Decision Date | 2022-07-14 |