The following data is part of a premarket notification filed by Shan Dong Wei Gao Group Medical Polymer Products with the FDA for Disposable Infusion Set.
| Device ID | K090012 |
| 510k Number | K090012 |
| Device Name: | DISPOSABLE INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS STE.8D, ZHONGXIN ZHONGSHAN MANSION,NO.19, LANE 999, ZHONG Shan Nan Er Rd., Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS STE.8D, ZHONGXIN ZHONGSHAN MANSION,NO.19, LANE 999, ZHONG Shan Nan Er Rd., Shanghai, CN 200030 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-02 |
| Decision Date | 2009-06-11 |
| Summary: | summary |