The following data is part of a premarket notification filed by Lsi Solutions with the FDA for Lsi Solutions Suture Quick Load Products.
| Device ID | K031443 |
| 510k Number | K031443 |
| Device Name: | LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | LSI SOLUTIONS 7796 VICTOR-MENDON RD. Victor, NY 14564 |
| Contact | Christopher A Klaczyk |
| Correspondent | Christopher A Klaczyk LSI SOLUTIONS 7796 VICTOR-MENDON RD. Victor, NY 14564 |
| Product Code | NEW |
| Subsequent Product Code | GAM |
| Subsequent Product Code | GAS |
| Subsequent Product Code | GAW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-06 |
| Decision Date | 2003-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850200006190 | K031443 | 000 |
| 10850200006183 | K031443 | 000 |
| 10850200006176 | K031443 | 000 |
| 00850200006162 | K031443 | 000 |
| 10850200006312 | K031443 | 000 |
| 10850200006145 | K031443 | 000 |