The following data is part of a premarket notification filed by Lsi Solutions with the FDA for Suture Placement Device And Accessories.
| Device ID | K981531 |
| 510k Number | K981531 |
| Device Name: | SUTURE PLACEMENT DEVICE AND ACCESSORIES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LSI SOLUTIONS 2144 BRIGHTON-HENRIETTA TOWN LINE RD. Rochester, NY 14623 |
| Contact | Jude S Sauer |
| Correspondent | Jude S Sauer LSI SOLUTIONS 2144 BRIGHTON-HENRIETTA TOWN LINE RD. Rochester, NY 14623 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-29 |
| Decision Date | 1998-07-13 |
| Summary: | summary |