The following data is part of a premarket notification filed by Orfit Industries Nv with the FDA for Nanor And Efficast/nanor Hybrid Thermoplastic Materials.
| Device ID | K131795 |
| 510k Number | K131795 |
| Device Name: | NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS |
| Classification | Accelerator, Linear, Medical |
| Applicant | ORFIT INDUSTRIES NV VOSVELD 9A Wijnegem, BE 2110 |
| Contact | Eddy Marivoet |
| Correspondent | Eddy Marivoet ORFIT INDUSTRIES NV VOSVELD 9A Wijnegem, BE 2110 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-18 |
| Decision Date | 2013-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420028755570 | K131795 | 000 |
| 05420028752357 | K131795 | 000 |
| 05420028752326 | K131795 | 000 |
| 05420028752074 | K131795 | 000 |
| 05420028752067 | K131795 | 000 |
| 05420028752036 | K131795 | 000 |
| 05420028751992 | K131795 | 000 |
| 05420028751954 | K131795 | 000 |
| 05420028751947 | K131795 | 000 |
| 05420028751893 | K131795 | 000 |
| 05420028751886 | K131795 | 000 |
| 05420028750346 | K131795 | 000 |
| 05420028725580 | K131795 | 000 |
| 05420028710227 | K131795 | 000 |
| 05420028752500 | K131795 | 000 |
| 05420028752883 | K131795 | 000 |
| 05420028768679 | K131795 | 000 |
| 05420028754382 | K131795 | 000 |
| 05420028754368 | K131795 | 000 |
| 05420028754337 | K131795 | 000 |
| 05420028754313 | K131795 | 000 |
| 05420028754306 | K131795 | 000 |
| 05420028754283 | K131795 | 000 |
| 05420028734124 | K131795 | 000 |
| 05420028725597 | K131795 | 000 |
| 05420028720554 | K131795 | 000 |
| 05420028717417 | K131795 | 000 |
| 05420028779415 | K131795 | 000 |
| 05420028776940 | K131795 | 000 |
| 05420028768815 | K131795 | 000 |
| 05420028700297 | K131795 | 000 |