The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Powerblade, Model 5005,5005-e,5005-c,5005-150,5000-c-150,5005-e-c-150,5005-420,5005-c-420,5005-e-420,5005-e-c-420,.
| Device ID | K063025 |
| 510k Number | K063025 |
| Device Name: | LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420, |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LINA MEDICAL APS 1289 N. FORDHAM BLVD. SUITE A- 128 Chapel Hill, NC 27517 |
| Contact | Walt Brittle |
| Correspondent | Walt Brittle LINA MEDICAL APS 1289 N. FORDHAM BLVD. SUITE A- 128 Chapel Hill, NC 27517 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-02 |
| Decision Date | 2006-12-01 |