The following data is part of a premarket notification filed by Anhui Tiankang Medical Technology Co.,ltd. with the FDA for Tk Insulin Syringe With/without Saftey Retractable Device.
| Device ID | K191639 |
| 510k Number | K191639 |
| Device Name: | TK Insulin Syringe With/without Saftey Retractable Device |
| Classification | Syringe, Antistick |
| 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 | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-19 |
| Decision Date | 2020-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784890524 | K191639 | 000 |
| 00616784890425 | K191639 | 000 |
| 00616784890326 | K191639 | 000 |
| 00616784890227 | K191639 | 000 |
| 00616784890128 | K191639 | 000 |
| M99208012905S5 | K191639 | 000 |