The following data is part of a premarket notification filed by Covidien with the FDA for Closurerfg Radiofrequency Generator.
| Device ID | K141858 |
| 510k Number | K141858 |
| Device Name: | CLOSURERFG RADIOFREQUENCY GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN 3033 Campus Drive Plymouth, MN 55441 |
| Contact | Laura Moen-ftacek |
| Correspondent | Laura Moen-ftacek COVIDIEN 3033 Campus Drive Plymouth, MN 55441 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-10 |
| Decision Date | 2014-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521713444 | K141858 | 000 |
| 10884521196544 | K141858 | 000 |
| 10884521777545 | K141858 | 000 |
| 10884521140394 | K141858 | 000 |