The following data is part of a premarket notification filed by Justright Surgical with the FDA for Justright Surgical Vessel Sealing System.
| Device ID | K160602 |
| 510k Number | K160602 |
| Device Name: | JustRight Surgical Vessel Sealing System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | JustRight Surgical 357 S. Mcaslin Blvd Suite 120 Louisville, CO 80027 |
| Contact | Jenifer Kennedy |
| Correspondent | Jenifer Kennedy JustRight Surgical 357 S. Mcaslin Blvd Suite 120 Louisville, CO 80027 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-02 |
| Decision Date | 2016-06-23 |
| Summary: | summary |