The following data is part of a premarket notification filed by Arplay Medical S.a. with the FDA for Immobilization System For Ent.
| Device ID | K003779 |
| 510k Number | K003779 |
| Device Name: | IMMOBILIZATION SYSTEM FOR ENT |
| Classification | Accelerator, Linear, Medical |
| Applicant | ARPLAY MEDICAL S.A. 1, ROUTE DE CITEAUX Izeure, Cote D'or, FR 21110 |
| Contact | Richard Borgi |
| Correspondent | Richard Borgi ARPLAY MEDICAL S.A. 1, ROUTE DE CITEAUX Izeure, Cote D'or, FR 21110 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-07 |
| Decision Date | 2001-07-12 |