The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Ektasian Hg Film (ehg-15).
| Device ID | K970154 |
| 510k Number | K970154 |
| Device Name: | KODAK EKTASIAN HG FILM (EHG-15) |
| Classification | Film, Radiographic |
| Applicant | EASTMAN KODAK COMPANY 1669 LAKE AVE. Rochester, NY 14652 |
| Contact | Maria Durkin |
| Correspondent | Maria Durkin EASTMAN KODAK COMPANY 1669 LAKE AVE. Rochester, NY 14652 |
| Product Code | IWZ |
| CFR Regulation Number | 892.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-16 |
| Decision Date | 1997-04-04 |