The following data is part of a premarket notification filed by Tianjin Medis International Trade Co., Ltd. with the FDA for Tianjin Medis Disposable Infusion Set.
| Device ID | K060082 |
| 510k Number | K060082 |
| Device Name: | TIANJIN MEDIS DISPOSABLE INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | TIANJIN MEDIS INTERNATIONAL TRADE CO., LTD. WANSHUN GARDEN C 1801 89# HUANGPU NAN ROAD Hexi District, Tianjin, CN 300201 |
| Contact | Cindy Wang |
| Correspondent | Cindy Wang TIANJIN MEDIS INTERNATIONAL TRADE CO., LTD. WANSHUN GARDEN C 1801 89# HUANGPU NAN ROAD Hexi District, Tianjin, CN 300201 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-10 |
| Decision Date | 2006-03-31 |