The following data is part of a premarket notification filed by Covidien with the FDA for Valleylab Ft10 Electrosurgical Platform.
| Device ID | K151649 |
| 510k Number | K151649 |
| Device Name: | Valleylab FT10 Electrosurgical Platform |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Sharon Mcdermott |
| Correspondent | Sharon Mcdermott COVIDIEN 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 | 2015-06-18 |
| Decision Date | 2015-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521640474 | K151649 | 000 |
| 10884521548350 | K151649 | 000 |
| 10884521516328 | K151649 | 000 |