The following data is part of a premarket notification filed by Mci Optonix, Inc. with the FDA for Rarex Green Fast.
| Device ID | K941023 |
| 510k Number | K941023 |
| Device Name: | RAREX GREEN FAST |
| Classification | Screen, Intensifying, Radiographic |
| Applicant | MCI OPTONIX, INC. P.O. BOX I 170 EAST HANOVER AVENUE Cedar Knolls, NJ 07927 |
| Contact | Joel Frey |
| Correspondent | Joel Frey MCI OPTONIX, INC. P.O. BOX I 170 EAST HANOVER AVENUE 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 | 1994-03-03 |
| Decision Date | 1994-03-30 |