The following data is part of a premarket notification filed by Mci Optonix, Inc. with the FDA for Rarex & Optex X-ray Screens.
| Device ID | K902039 |
| 510k Number | K902039 |
| Device Name: | RAREX & OPTEX X-RAY SCREENS |
| Classification | Screen, Intensifying, Radiographic |
| Applicant | MCI OPTONIX, INC. HANOVER AVE. AND HORSEHILL RD. P.O. BOX 1 Cedar Knolls, NJ 07927 |
| Contact | John Daforno |
| Correspondent | John Daforno MCI OPTONIX, INC. HANOVER AVE. AND HORSEHILL RD. P.O. BOX 1 Cedar Knolls, NJ 07927 |
| Product Code | EAM |
| CFR Regulation Number | 892.1960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-04 |
| Decision Date | 1990-07-27 |