The following data is part of a premarket notification filed by Pollogen Ltd. with the FDA for Pollogen Legend+ System.
| Device ID | K171359 |
| 510k Number | K171359 |
| Device Name: | Pollogen Legend+ System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Pollogen Ltd. 6 Kaufman St. Tel Aviv, IL 6801298 |
| Contact | Ilana Dessow Lironne |
| Correspondent | Elissa Burg BioVision Ltd Had Nes 183 Had Nes, IL 1295000 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-09 |
| Decision Date | 2017-09-13 |
| Summary: | summary |