The following data is part of a premarket notification filed by Iskra Medical, D.o.o. with the FDA for Iskra Medical Green Irf Prestige.
| Device ID | K083590 |
| 510k Number | K083590 |
| Device Name: | ISKRA MEDICAL GREEN IRF PRESTIGE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ISKRA MEDICAL, D.O.O. STEGNE 23 Ljubljana, SI 1000 |
| Contact | Mojca Valjavec |
| Correspondent | Mojca Valjavec ISKRA MEDICAL, D.O.O. STEGNE 23 Ljubljana, SI 1000 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-04 |
| Decision Date | 2009-04-17 |
| Summary: | summary |