The following data is part of a premarket notification filed by Foosin Medical Supplies Inc., Ltd with the FDA for Wego-pgla Rapid.
| Device ID | K183001 |
| 510k Number | K183001 |
| Device Name: | WEGO-PGLA RAPID |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Foosin Medical Supplies Inc., Ltd No.20, Xingshan Road, Weihai Torch Hi-tech Science Park Weihai, CN 264210 |
| Contact | Lei Tang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-30 |
| Decision Date | 2019-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06941813699811 | K183001 | 000 |