The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Powerblade Plus.
| Device ID | K132837 |
| 510k Number | K132837 |
| Device Name: | LINA POWERBLADE PLUS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LINA MEDICAL APS 386 WEST MAIN ST. SUITE 7 Northborough, MA 01532 |
| Contact | Christine E Nichols |
| Correspondent | Christine E Nichols LINA MEDICAL APS 386 WEST MAIN ST. SUITE 7 Northborough, MA 01532 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-10 |
| Decision Date | 2013-12-19 |
| Summary: | summary |