The following data is part of a premarket notification filed by Covidien Lp, Formerly Know As Valleylab, A Divison with the FDA for Forcetriad Electrosurgical Generator.
| Device ID | K110268 |
| 510k Number | K110268 |
| Device Name: | FORCETRIAD ELECTROSURGICAL GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Donald Henton |
| Correspondent | Donald Henton COVIDIEN LP, FORMERLY KNOW AS VALLEYLAB, A DIVISON 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-28 |
| Decision Date | 2011-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521062092 | K110268 | 000 |
| 10884521062085 | K110268 | 000 |
| 10884521129498 | K110268 | 000 |
| 10884521133310 | K110268 | 000 |
| 10884521035379 | K110268 | 000 |
| 10884524001531 | K110268 | 000 |
| 10884524002903 | K110268 | 000 |