The following data is part of a premarket notification filed by Foosin Medical Supplies Inc., Ltd. with the FDA for Wego-ptfe.
| Device ID | K170842 |
| 510k Number | K170842 |
| Device Name: | WEGO-PTFE |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| 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 Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | NBY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-21 |
| Decision Date | 2017-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814639023699 | K170842 | 000 |
| 10814639024057 | K170842 | 000 |
| 10814639024842 | K170842 | 000 |
| 10814639024859 | K170842 | 000 |
| 00814639023619 | K170842 | 000 |
| 20814639023620 | K170842 | 000 |
| 20814639023637 | K170842 | 000 |
| 20814639023644 | K170842 | 000 |
| 20814639023651 | K170842 | 000 |
| 20814639023668 | K170842 | 000 |
| 20814639023675 | K170842 | 000 |
| 20814639023682 | K170842 | 000 |
| 10814639022237 | K170842 | 000 |