The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Safeair Smoke Pencil.
| Device ID | K142538 |
| 510k Number | K142538 |
| Device Name: | LiNA SafeAir Smoke Pencil |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LINA MEDICAL APS FORMERVAGEN 5 Glostrup, DK 2600 |
| Contact | Louisa Memborg |
| Correspondent | Christine E Nichols Boston Biomedical Associates 100 Crowley Dr., Suite 216 Marlborough, MA 01752 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-09 |
| Decision Date | 2014-10-06 |
| Summary: | summary |