The following data is part of a premarket notification filed by Foosin Medical Supplies Inc.ltd with the FDA for Synthetic Absorbable Suture.
| Device ID | K130737 |
| 510k Number | K130737 |
| Device Name: | SYNTHETIC ABSORBABLE SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | FOOSIN MEDICAL SUPPLIES INC.LTD PO BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong FOOSIN MEDICAL SUPPLIES INC.LTD PO 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 | 2013-03-18 |
| Decision Date | 2014-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814639022968 | K130737 | 000 |
| 00840118611336 | K130737 | 000 |
| 00840118614740 | K130737 | 000 |
| 10814639026105 | K130737 | 000 |
| 10814639025535 | K130737 | 000 |
| 10814639025542 | K130737 | 000 |
| 10814639024873 | K130737 | 000 |
| B031MVY3440 | K130737 | 000 |
| B031MVY3450 | K130737 | 000 |
| B031MVY3460 | K130737 | 000 |
| B031MVY9220 | K130737 | 000 |
| B031MVY9230 | K130737 | 000 |
| B031MVY9420 | K130737 | 000 |
| B031MVY9430 | K130737 | 000 |
| B031MVY9670 | K130737 | 000 |
| B031MVY9870 | K130737 | 000 |
| 00817169021131 | K130737 | 000 |
| 00840118611329 | K130737 | 000 |