The following data is part of a premarket notification filed by Lsi Solutions with the FDA for Lsi Sew-right R Series Suture Placement Device And Access Product Sew-right Sr-5r, Model 020999.
| Device ID | K040232 |
| 510k Number | K040232 |
| Device Name: | LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-02 |
| Decision Date | 2004-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850200006121 | K040232 | 000 |
| 10850200006114 | K040232 | 000 |