The following data is part of a premarket notification filed by Lsi Solutions, Inc. with the FDA for Suture Placement Device And Accessories, Flexible Suture Placement Device And Accessories, Lsi R Series Suture Placeme.
| Device ID | K100593 |
| 510k Number | K100593 |
| Device Name: | SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | LSI SOLUTIONS, INC. 7796 VICTOR-MENDON RD. Victor, NY 14564 |
| Contact | Peter Spath |
| Correspondent | Peter Spath LSI SOLUTIONS, INC. 7796 VICTOR-MENDON RD. Victor, NY 14564 |
| Product Code | GAW |
| Subsequent Product Code | GAS |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | HCF |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-02 |
| Decision Date | 2010-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850200006350 | K100593 | 000 |
| 10850200006145 | K100593 | 000 |
| 10850200006138 | K100593 | 000 |
| 10850200006107 | K100593 | 000 |
| 10850200006091 | K100593 | 000 |
| 10850200006084 | K100593 | 000 |
| 10850200006077 | K100593 | 000 |
| 10850200006053 | K100593 | 000 |
| 00850200006896 | K100593 | 000 |
| 10850200006619 | K100593 | 000 |
| 10850200006152 | K100593 | 000 |
| 10850200006206 | K100593 | 000 |
| 10850200006343 | K100593 | 000 |
| 10850200006336 | K100593 | 000 |
| 10850200006312 | K100593 | 000 |
| 10850200006305 | K100593 | 000 |
| 10850200006299 | K100593 | 000 |
| 10850200006282 | K100593 | 000 |
| 10850200006275 | K100593 | 000 |
| 10850200006251 | K100593 | 000 |
| 10850200006244 | K100593 | 000 |
| 10850200006534 | K100593 | 000 |