The following data is part of a premarket notification filed by Lsi Soultions with the FDA for Pledgeted Cor-suture Quick Load.
| Device ID | K160529 |
| 510k Number | K160529 |
| Device Name: | Pledgeted COR-SUTURE QUICK LOAD |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | LSI SOULTIONS 7796 VICTOR-MENDON RD Victor, NY 14564 |
| Contact | Kevin Bentley |
| Correspondent | Kevin Bentley LSI SOULTIONS 7796 VICTOR-MENDON RD Victor, NY 14564 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-25 |
| Decision Date | 2016-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850200006435 | K160529 | 000 |
| 10850200006459 | K160529 | 000 |
| 10850200006466 | K160529 | 000 |
| 10850200006473 | K160529 | 000 |
| 10850200006480 | K160529 | 000 |
| 10850200006763 | K160529 | 000 |
| 10850200006770 | K160529 | 000 |
| 10850200006787 | K160529 | 000 |
| 10850200006794 | K160529 | 000 |
| 10850200006800 | K160529 | 000 |
| 10850200006817 | K160529 | 000 |
| 10850200006824 | K160529 | 000 |
| 10850200006404 | K160529 | 000 |
| 10850200006442 | K160529 | 000 |