The following data is part of a premarket notification filed by Uresil Corp. with the FDA for Mini-op Laparoscopic Lasso.
| Device ID | K944784 |
| 510k Number | K944784 |
| Device Name: | MINI-OP LAPAROSCOPIC LASSO |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Contact | Lev Melinsyshyn |
| Correspondent | Lev Melinsyshyn URESIL CORP. 5418 W. TOUHY AVE. Skokie, IL 60077 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1994-10-28 |