The following data is part of a premarket notification filed by Polaroid Corp. with the FDA for Polaroid Tpx Radiographic Film.
| Device ID | K811352 |
| 510k Number | K811352 |
| Device Name: | POLAROID TPX RADIOGRAPHIC FILM |
| Classification | Film, Radiographic |
| Applicant | POLAROID CORP. 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 | 1981-05-14 |
| Decision Date | 1981-06-18 |