The following data is part of a premarket notification filed by Covidien with the FDA for Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil.
| Device ID | K182772 |
| 510k Number | K182772 |
| Device Name: | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Covidien 5920 Longbow Drive Boulder, CO 80301 |
| Contact | Jennie Van Diemen |
| Correspondent | Jennie Van Diemen 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 | 2018-10-01 |
| Decision Date | 2018-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521751122 | K182772 | 000 |
| 10884521750906 | K182772 | 000 |
| 20884521750927 | K182772 | 000 |
| 20884521750613 | K182772 | 000 |
| 30884521750917 | K182772 | 000 |
| 30884521750931 | K182772 | 000 |
| 30884521751136 | K182772 | 000 |
| 30884521751143 | K182772 | 000 |
| 20884521750590 | K182772 | 000 |
| 10884521750609 | K182772 | 000 |