The following data is part of a premarket notification filed by Shan Dong Wei Gao Group Medical Polymer Products with the FDA for Disposable Tpe Infusion Set.
Device ID | K090459 |
510k Number | K090459 |
Device Name: | DISPOSABLE TPE INFUSION SET |
Classification | Set, Administration, Intravascular |
Applicant | SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS STE.8D, ZHONGXIN ZHONGSHAN #2 ROADY ,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 #2 ROADY ,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 | 2009-02-23 |
Decision Date | 2009-10-13 |
Summary: | summary |