The following data is part of a premarket notification filed by Justright Surgical, Llc with the FDA for The Justright Surgical Vessel Sealing System.
| Device ID | K123662 |
| 510k Number | K123662 |
| Device Name: | THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | JUSTRIGHT SURGICAL, LLC 128 Blye HIll Landing Newbury, NH 03255 |
| Contact | Michele Lucey |
| Correspondent | Michele Lucey JUSTRIGHT SURGICAL, LLC 128 Blye HIll Landing Newbury, NH 03255 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-28 |
| Decision Date | 2013-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865163000133 | K123662 | 000 |
| 10865163000123 | K123662 | 000 |