The following data is part of a premarket notification filed by Anhui Tiankang Medical Products Co., Ltd with the FDA for Tiankang Disposable Syringes With Re-use Prevention Feature With Or Without Needle.
| Device ID | K131531 |
| 510k Number | K131531 |
| Device Name: | TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE |
| Classification | Syringe, Antistick |
| Applicant | ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD NO. 20 SOUTH RENHE ROAD Tianchang City, Anhui Province, CN 239300 |
| Contact | Xiuming Chong |
| Correspondent | Xiuming Chong ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD NO. 20 SOUTH RENHE ROAD Tianchang City, Anhui Province, 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 | 2013-05-28 |
| Decision Date | 2014-05-12 |
| Summary: | summary |