The following data is part of a premarket notification filed by Mci Optonix, Inc. with the FDA for Mci Optonix Economy Cassette.
| Device ID | K953444 |
| 510k Number | K953444 |
| Device Name: | MCI OPTONIX ECONOMY CASSETTE |
| Classification | Cassette, Radiographic Film |
| 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 | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-17 |
| Decision Date | 1995-08-02 |