The following data is part of a premarket notification filed by Wuhan W.e.o Science & Technology Development Co., Ltd. with the FDA for Infusion Sets With Precision Filter For Single Use, Precision Infusion Filter For Single Use, Extended Infusion Sets For Single Use.
| Device ID | K181870 |
| 510k Number | K181870 |
| Device Name: | Infusion Sets With Precision Filter For Single Use, Precision Infusion Filter For Single Use, Extended Infusion Sets For Single Use |
| Classification | Set, Administration, Intravascular |
| Applicant | Wuhan W.E.O Science & Technology Development Co., Ltd. No.18, Huanhu Mid. Rd., Jinyin Lake, Dongxihu Dist Wuhun, CN 430040 |
| Contact | Chengling Fu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-12 |
| Decision Date | 2019-02-26 |
| Summary: | summary |