The following data is part of a premarket notification filed by Lsi Solutions with the FDA for Lsi Solutions Flexible Suture Placement Device And Accessories Product.
| Device ID | K011016 |
| 510k Number | K011016 |
| Device Name: | LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LSI SOLUTIONS 2144 BRIGHTON-HENRIETTA TOWN LINE RD. Rochester, NY 14623 |
| Contact | Christine E Ehmann |
| Correspondent | Christine E Ehmann LSI SOLUTIONS 2144 BRIGHTON-HENRIETTA TOWN LINE RD. Rochester, NY 14623 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-04 |
| Decision Date | 2001-04-27 |