The following data is part of a premarket notification filed by Radiation Products Design, Inc. with the FDA for Mylar Window-table Insert Panel.
| Device ID | K800791 |
| 510k Number | K800791 |
| Device Name: | MYLAR WINDOW-TABLE INSERT PANEL |
| Classification | Accelerator, Linear, Medical |
| Applicant | RADIATION PRODUCTS DESIGN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-08 |
| Decision Date | 1980-05-14 |