The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Safeair Telescopic Smoke Pencil.
| Device ID | K182354 |
| 510k Number | K182354 |
| Device Name: | SafeAir Telescopic Smoke Pencil |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LiNA Medical ApS Formervangen 5 Glostrup, DK 2600 |
| Contact | Natalia Szychulska |
| Correspondent | Kevin F. Macdonald Macdonald Regulatory Consulting 4297 D Street Sacramento, CA 95819 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-29 |
| Decision Date | 2018-12-14 |
| Summary: | summary |