The following data is part of a premarket notification filed by Unidex Group, Inc. with the FDA for Radiographic Film Cassettes.
| Device ID | K962336 |
| 510k Number | K962336 |
| Device Name: | RADIOGRAPHIC FILM CASSETTES |
| Classification | Cassette, Radiographic Film |
| Applicant | UNIDEX GROUP, INC. 2400 EAST DEVON AVE., SUITE 205 Des Plaines, IL 60018 |
| Contact | Henry Lee |
| Correspondent | Henry Lee UNIDEX GROUP, INC. 2400 EAST DEVON AVE., SUITE 205 Des Plaines, IL 60018 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1996-07-03 |