The following data is part of a premarket notification filed by Gilardoni S.p.a. with the FDA for Gridgil.
| Device ID | K941626 |
| 510k Number | K941626 |
| Device Name: | GRIDGIL |
| Classification | Grid, Radiographic |
| Applicant | GILARDONI S.P.A. 2, VIA FERMI Mandello Lario, IT 22054 |
| Contact | Cristina Gilardoni |
| Correspondent | Cristina Gilardoni GILARDONI S.P.A. 2, VIA FERMI Mandello Lario, IT 22054 |
| Product Code | IXJ |
| CFR Regulation Number | 892.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-04 |
| Decision Date | 1994-05-13 |