The following data is part of a premarket notification filed by Foosin Medical Supplies Inc., Ltd. with the FDA for Wego-stainless Steel.
| Device ID | K193209 |
| 510k Number | K193209 |
| Device Name: | Wego-Stainless Steel |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | Foosin Medical Supplies Inc., Ltd. No.20, Xingshan Road, Weihai Torch Hi-tech Science Park Weihai, CN 264210 |
| Contact | Zhipeng Yang |
| Correspondent | Diana Hong Med-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-21 |
| Decision Date | 2020-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814639025764 | K193209 | 000 |
| 10814639025757 | K193209 | 000 |
| 10814639025740 | K193209 | 000 |