The following data is part of a premarket notification filed by Palex Intl. Sa with the FDA for Contorno (tm).
| Device ID | K902642 |
| 510k Number | K902642 |
| Device Name: | CONTORNO (TM) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PALEX INTL. SA CARRETERA DE TERRASSA, 121 08191 RUBI' (BARCELONA) Spain, ES |
| Contact | Martin A Jordan |
| Correspondent | Martin A Jordan PALEX INTL. SA CARRETERA DE TERRASSA, 121 08191 RUBI' (BARCELONA) Spain, ES |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-14 |
| Decision Date | 1990-08-07 |