The following data is part of a premarket notification filed by Smit Rontgen with the FDA for Fibre Interspaced X-ray Grid.
| Device ID | K963893 |
| 510k Number | K963893 |
| Device Name: | FIBRE INTERSPACED X-RAY GRID |
| Classification | Grid, Radiographic |
| Applicant | SMIT RONTGEN POSTBOX 218 Md Eindhoven, NL 5600 |
| Contact | Ing. R.w. Rijntjes |
| Correspondent | Ing. R.w. Rijntjes SMIT RONTGEN POSTBOX 218 Md Eindhoven, NL 5600 |
| Product Code | IXJ |
| CFR Regulation Number | 892.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-27 |
| Decision Date | 1996-11-07 |
| Summary: | summary |