The following data is part of a premarket notification filed by Covidien Llc with the FDA for Valleylab Ls10 Generator.
| Device ID | K143654 |
| 510k Number | K143654 |
| Device Name: | Valleylab LS10 Generator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN LLC 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Donald Henton |
| Correspondent | Donald Henton COVIDIEN LLC 5920 LONGBOW DRIVE 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 | 2014-12-23 |
| Decision Date | 2015-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521780583 | K143654 | 000 |
| 10884521512801 | K143654 | 000 |