The following data is part of a premarket notification filed by Foosin Medical Supplies Inc., Ltd with the FDA for Wego-pga Rapid.
| Device ID | K183004 |
| 510k Number | K183004 |
| Device Name: | WEGO-PGA 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 |
|---|---|---|
| 20815131027581 | K183004 | 000 |
| 10814639024330 | K183004 | 000 |
| 30814639022217 | K183004 | 000 |
| 10814639022206 | K183004 | 000 |
| 10814639022190 | K183004 | 000 |
| 10814639022183 | K183004 | 000 |
| 10814639022176 | K183004 | 000 |
| 10814639025528 | K183004 | 000 |
| 00840118613637 | K183004 | 000 |
| 00840118611039 | K183004 | 000 |
| 00840118610742 | K183004 | 000 |
| 00840118610728 | K183004 | 000 |
| 00840118610704 | K183004 | 000 |
| 10814639024347 | K183004 | 000 |
| 10814639024354 | K183004 | 000 |
| 00814639024364 | K183004 | 000 |
| 10814639024927 | K183004 | 000 |
| 10814639024910 | K183004 | 000 |
| 10814639024903 | K183004 | 000 |
| 10814639024897 | K183004 | 000 |
| 10814639024835 | K183004 | 000 |
| 10814639024439 | K183004 | 000 |
| 10814639024422 | K183004 | 000 |
| 10814639024415 | K183004 | 000 |
| 10814639024408 | K183004 | 000 |
| 10814639024392 | K183004 | 000 |
| 10814639024385 | K183004 | 000 |
| 10814639024378 | K183004 | 000 |
| 00840118610681 | K183004 | 000 |