The following data is part of a premarket notification filed by Hope Industries, Inc. with the FDA for Hope Model 126, Auto/proces., Den. Flm.
| Device ID | K800134 |
| 510k Number | K800134 |
| Device Name: | HOPE MODEL 126, AUTO/PROCES., DEN. FLM |
| Classification | Film, Radiographic |
| Applicant | HOPE INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IWZ |
| CFR Regulation Number | 892.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-21 |
| Decision Date | 1980-05-02 |